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Prescription medicines: new or extended uses, or new combinations of registered medicines

5 December 2019

Over time, the approved therapeutic uses of prescription medicines registered on the Australian Register of Therapeutic Goods (ARTG) can change.

Changes commonly include 'new uses' or 'extended uses'. A new use is where an already registered medicine is approved for an additional therapeutic use. An extended use is where an already registered medicine is approved to treat a broader range of patients, e.g. a wider age range. New or extended uses are called 'extensions of indications'. By contrast, a 'new combination' is where two or more already registered medicines are combined into a single product.

The decision to approve an 'extension of indications' or 'new combination' for already registered prescription medicines follows a comprehensive review by TGA scientists and clinicians on the quality, safety and efficacy of the proposed use of the medicine.

Throughout the year, we will be publishing information relating to new or extended uses, or new combinations of registered prescription medicines on the TGA website.

The trade name, active ingredient, and sponsor for each medicine reflects the information entered into the ARTG when the new or extended use was first approved. This webpage provides a summary of the newly added indications; for a full list of each medicine's registered indications, please refer to the Product Information database.

Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. TGA works to business target timeframes as well as to legislated timeframes for each category of application. Approval times are underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, the time allocated to the sponsor to respond to requests for information, 'mutual clock stop' periods agreed with the sponsor, or other review activities.

Approval times are reported in the number of TGA working days for each new registration, along with the legislated timeframe (unless otherwise indicated) for that category of application in brackets.


symbol denoting an orphan drug

Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market

symbol denoting a priority determination

Priority review: involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available

symbol denoting a provisional registration

Provisional registration: involves early access to vital and life-saving medicines through time-limited registration


Registration of new or extended uses of registered medicines, 2019

Previous years

2018 2017 2016

November 2019

SYMTUZA

Evaluation commenced: 31 Jan 2019

Registration decision: 20 Nov 2019

Date registered: 22 Nov 2019

Approval time: 184 working days (255)

darunavir/cobicistat/emtricitabine/tenofovir alafenamide

Janssen-Cilag Pty Ltd

New combination

SYMTUZA (film-coated tablets) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). Genotypic testing should guide the use of SYMTUZA (see section 4.2 Dose and method of administration, section 4.4 Special warnings and precautions for use and section 5.1 Pharmacodynamic properties).

CIMZIA

Evaluation commenced: 31 Dec 2018

Registration decision: 13 Nov 2019

Date registered: 18 Nov 2019

Approval time: 193 working days (255)

certolizumab pegol

UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

Non-radiographic Axial Spondyloarthritis

CIMZIA (solution for injection) is now also indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated Creactive protein (CRP) and/ or magnetic resonance imaging (MRI) change, who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (NSAIDs).

CEFUROXIME ANS, CEFUROXIME SXP

Evaluation commenced: 30 Nov 2018

Registration decision: 7 Nov 2019

Date registered: 14 Nov 2019

Approval time: 161 working days (255)

cefuroxime sodium

Southern Cross Pharma Pty Ltd

CEFUROXIME ANS, CEFUROXIME SXP (powder for injection) is indicated in adults and children of 40 kg or greater in weight for the prevention of infections associated with certain surgical procedures of the gastrointestinal (including oesophageal), orthopaedic, cardiovascular and gynaecological systems (including caesarean section) (see SECTION 4.4: SPECIAL WARNINGS AND PRECAUTIONS FOR USE and SECTION 5.2: PHARMACOKINETIC PROPERTIES).

In the prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents such as metronidazole.

Consideration should be given to official guidance on the appropriate use of antibacterial agents, as antibiotic prophylaxis is not required in all gastrointestinal, orthopaedic, cardiovascular and gynaecological procedures or surgeries.

For patients with specific cardiac conditions which predispose them to endocarditis who are undergoing abdominal surgery for which surgical antibiotic prophylaxis is indicated, the prophylaxis regimen should additionally include an antibiotic active against enterococci.

For patients undergoing orthopaedic or cardiovascular surgery known to be, or at risk of being, colonised or infected with methicillin-resistant S. aureus (MRSA), add an antibiotic with activity against MRSA, such as vancomycin.

CEFUROXIME ANS, CEFUROXIME SXP is not indicated in children < 40 kg in weight.

LABETALOL RMB, LABETALOL SXP, LABETALOL TLB

Evaluation commenced: 31 Jul 2018

Registration decision: 23 Aug 2019

Date registered: 14 Nov 2019

Approval time: 248 working days (255)

labetalol hydrochloride

Southern Cross Pharma Pty Ltd

LABETALOL RMB, LABETALOL SXP, LABETALOL TLB (solution for injection) is indicated for the emergency treatment of severe hypertension when prompt and urgent reduction of blood pressure is essential.

TRESIBA FLEXTOUCH, TRESIBA PENFILL

Evaluation commenced: 31 Aug 2018

Registration decision: 13 Nov 2019

Date registered: 14 Nov 2019

Approval time: 234 working days (255)

insulin degludec

Novo Nordisk Pharmaceuticals Pty Ltd

TRESIBA FLEXTOUCH, TRESIBA PENFILL (solution for injection) is now also indicated for the treatment of diabetes mellitus in adolescents and children from the age of 1 year.

UTROGESTAN 200

Evaluation commenced: 3 Jan 2019

Registration decision: 12 Nov 2019

Date registered: 13 Nov 2019

Approval time: 194 working days (255)

progesterone

Besins Healthcare Australia Pty Ltd

UTROGESTAN 200 (soft capsules) is now also indicated for:

Support during pregnancy
  • Prevention of preterm birth in women with singleton pregnancy who have a short cervix (midtrimester sonographic cervix ≤25 mm) and/or a history of spontaneous preterm birth.

ORIPRO

Evaluation commenced: 30 Nov 2018

Registration decision: 6 Nov 2019

Date registered: 12 Nov 2019

Approval time: 189 working days (255)

progesterone

Orion Laboratories Pty Ltd T/A Perrigo Australia

ORIPRO (pessaries) is now also indicated for prevention of preterm birth in singleton pregnancies at risk due to:

  • Shortened cervix (midtrimester sonographic cervix ≤25 mm) and/or
  • Where there is a history of spontaneous preterm birth.

PRALUENT

Evaluation commenced: 31 Aug 2018

Registration decision: 29 Oct 2019

Date registered: 1 Nov 2019

Approval time: 209 working days (255)

alirocumab

Sanofi-Aventis Australia Pty Ltd

Primary hypercholesterolaemia

PRALUENT is indicated as an adjunct to diet and exercise to reduce LDL-C in adults with primary (heterozygous familial or non-familial) hypercholesterolaemia in patients with moderate to very high cardiovascular risk:

  • In combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with maximum tolerated dose of a statin,
  • alone or in combination with other lipid lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated who are unable to reach LDL-C goals.
Prevention of cardiovascular events

PRALUENT is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke, unstable angina requiring hospitalisation) in adults with established cardiovascular disease, in combination with optimally dosed statins and/or other lipid-lowering therapies (see section 5.1 Pharmacodynamic properties, CLINICAL TRIALS).

October 2019

DUPIXENT

Evaluation commenced: 2 Jan 2019

Registration decision: 25 Oct 2019

Date registered: 31 Oct 2019

Approval time: 158 working days (255)

dupilumab

Sanofi-Aventis Australia Pty Ltd

Atopic Dermatitis

DUPIXENT (solution for injection) is now also indicated for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and older who are candidates for chronic systemic therapy. Dupixent is not intended for episodic use.

TIVICAY

Evaluation commenced: 31 Jan 2019

Registration decision: 23 Oct 2019

Date registered: 30 Oct 2019

Approval time: 166 working days (255)

dolutegravir

ViiV Healthcare Pty Ltd

TIVICAY (film-coated tablet) is now indicated for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in adults and children over 6 years of age (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE - Dual regimens).

TECENTRIQ provisional registration

Evaluation commenced: 11 Jul 2019

Registration decision: 16 Oct 2019

Date registered: 24 Oct 2019

Approval time: 69 working days (255)

atezolizumab

Roche Products Pty Ltd

Triple-negative breast cancer

TECENTRIQ (concentrated solution for injection), in combination with paclitaxel protein-bound, is now also indicated for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] of any intensity covering ≥ 1% of the tumour), as determined by a validated test and who have not received prior chemotherapy for metastatic disease. This indication is approved under provisional approval based on progression free survival. Continued approval for this indication depends on verification and description of clinical benefit in a confirmatory trial(s).

JANUMET HCI, JANUMET XR, VELMETIA, VELMETIA XR

Evaluation commenced: 2 Jan 2019

Registration decision: 9 Oct 2019

Date registered: 14 Oct 2019

Approval time: 150 working days (255)

sitagliptin phosphate monohydrate; metformin hydrochloride

Merck Sharp & Dohme (Australia) Pty Ltd

JANUMET, JANUMET XR, VELMETIA, VELMETIA XR (film coated tablet, extended release tablet, modified release tablet) are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate. [see Sections 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and 4.2 DOSE AND METHOD OF ADMINISTRATION]

JANUVIA, XELEVIA

Evaluation commenced: 2 Jan 2019

Registration decision: 9 Oct 2019

Date registered: 14 Oct 2019

Approval time: 150 working days (255)

sitagliptin phosphate monohydrate

Merck Sharp & Dohme (Australia) Pty Ltd

JANUVIA, XELEVIA (film coated tablet) are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:

  • monotherapy when metformin is considered inappropriate due to intolerance; or
  • in combination with other anti-hyperglycaemic agents, including insulin.

[see Sections 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials, and 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS for available data on different add-on combination therapies].

UVADEX orphan drug

Evaluation commenced: 30 Nov 2018

Registration decision: 8 Oct 2019

Date registered: 11 Oct 2019

Approval time: 175 working days (255)

methoxsalen

Terumo BCT Australia Pty Ltd

UVADEX (concentrated solution for injection) is indicated for extracorporeal administration with the THERAKOS CELLEX Photopheresis System for the:

  • treatment of steroid-refractory and steroid-intolerant chronic graft versus host disease (cGVHD) in adults following allogeneic HSC transplantation.
  • palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment.

September 2019

KADCYLA priority review

Evaluation commenced: 1 May 2019

Registration decision: 26 Sep 2019

Date registered: 27 Sep 2019

Approval time: 105 working days (255)

trastuzumab emtansine (rch)

Roche Products Pty Ltd

Early breast cancer

KADCYLA (powder for injection), as a single agent, is now also indicated for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

LENVIMA provisional registration

Evaluation commenced: 4 Jul 2019

Registration decision: 17 Sep 2019

Date registered: 17 Sep 2019

Approval time: 54 working days (255)

lenvatinib mesilate

Eisai Australia Pty Ltd

LENVIMA (hard capsules), in combination with pembrolizumab, is now also indicated for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single-arm trial. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.

KEYTRUDA provisional registration

Evaluation commenced: 4 Jul 2019

Registration decision: 17 Sep 2019

Date registered: 17 Sep 2019

Approval time: 54 working days (255)

pembrolizumab

Merck Sharp & Dohme (Australia) Pty Ltd

KEYTRUDA (powder for injection, concentrated solution for injection), in combination with lenvatinib, is now also indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in a single-arm trial. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.

DOVATO

Evaluation commenced: 31 Oct 2018

Registration decision: 11 Sep 2019

Date registered: 12 Sep 2019

Approval time: 201 working days (255)

dolutegravir, lamivudine

ViiV Healthcare Pty Ltd

New combination

DOVATO (tablets) is indicated for the treatment of Human Immunodeficiency Virus-1 (HIV-1) infection in antiretroviral treatment-naïve adults and adolescents (from 12 years of age weighing at least 40 kg) who have no known or suspected resistance to either antiretroviral component.

XTANDI

Evaluation commenced: 31 Oct 2018

Registration decision: 6 Sep 2019

Date registered: 10 Sep 2019

Approval time: 173 working days (255)

enzalutamide

Astellas Pharma Australia Pty Ltd

XTANDI (soft capsules) is now also indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

August 2019

FLUQUADRI

Evaluation commenced: 31 Oct 2018

Registration decision: 15 Aug 2019

Date registered: 22 Aug 2019

Approval time: 178 working days (255)

influenza virus haemagglutinin

Sanofi-Aventis Australia Pty Ltd

FLUQUADRI (suspension for injection) is indicated for active immunisation of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

FLUQUADRI is now indicated for use in adults and children 6 months and older.

IMBRUVICA

Evaluation commenced: 2 Jan 2019

Registration decision: 21 Aug 2019

Date registered: 22 Aug 2019

Approval time: 138 working days (255)

ibrutinib

Janssen-Cilag Pty Ltd

IMBRUVICA (capsules) is indicated for the treatment of patients with MCL who have received at least one prior therapy.

IMBRUVICA as a single agent is indicated for the treatment of adult patients with Waldenstrom's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.

IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with Waldenstrom's macroglubulinaemia (WM).

IMBRUVICA as a single agent or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic leukemia (CLL/SLL). Can be used in patients with deletion 17p.

IMBRUVICA as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia/small lymphocytic leukemia (CLL/SLL) who have received at least one prior therapy. Can be used in patients with deletion 17p.

NOVISTIG

Evaluation commenced: 2 Jul 2018

Registration decision: 19 Aug 2019

Date registered: 20 Aug 2019

Approval time: 228 working days (255)

neostigmine methylsulfate; glycopyrronium bromide (glycopyrrolate)

Boucher & Muir Pty Ltd

NOVISTIG (solution for injection) is indicated for reversal of residual non-depolarising (competitive) neuromuscular block.

REVLIMID

Evaluation commenced: 28 Sep 2018

Registration decision: 16 Aug 2019

Date registered: 16 Aug 2019

Approval time: 187 working days (255)

lenalidomide

Celgene Pty Ltd

Multiple Myeloma (MM)

REVLIMID (capsules) is now also indicated for treatment of multiple myeloma.

ACTIKERALL

Evaluation commenced: 28 Apr 2017

Registration decision: 13 Sep 2018

Date registered: 15 Aug 2019

Approval time: 190 working days (255)

fluorouracil; salicylic acid

A Menarini Australia Pty Ltd

ACTIKERALL (topical solution) is indicated for the topical treatment of solar (actinic) keratosis.

KISQALI

Evaluation commenced: 31 Jul 2018

Registration decision: 7 Aug 2019

Date registered: 9 Aug 2019

Approval time: 194 working days (255)

ribociclib (as succinate)

Novartis Pharmaceuticals Australia Pty Ltd

KISQALI (film coated tablets) is indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with an aromatase inhibitor or fulvestrant, as initial endocrine-based therapy or following prior endocrine therapy.

In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

KEYTRUDA

Evaluation commenced: 30 Nov 2018

Registration decision: 5 Aug 2019

Date registered: 8 Aug 2019

Approval time: 149 working days (255)

pembrolizumab

Merck Sharp & Dohme (Australia) Pty Ltd

KEYTRUDA (powder for injection, solution for injection) is now also indicated as monotherapy for the first-line treatment of patients with NSCLC expressing PD-L1 [tumour proportion score (TPS) ≥1%] as determined by a validated test, with no EGFR or ALK genomic tumour aberrations, and is:

  • stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
  • metastatic.

ILUVIEN

Evaluation commenced: 1 Aug 2018

Registration decision: 30 Jul 2019

Date registered: 6 Aug 2019

Approval time: 206 working days (255)

fluocinolone acetonide

Specialised Therapeutics Alim Pty Ltd

ILUVIEN (intravitreal implant) is now also indicated for the treatment of diabetic macular oedema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP).

July 2019

RISPERIDONE GENERICHEALTH

Evaluation commenced: 21 Feb 2019

Registration decision: 14 May 2019

Date registered: 31 Jul 2019

Approval time: 45 working days (45)

risperidone

Generic Health Pty Ltd

Generic medicine

RISPERIDONE GENERICHEALTH (tablets) are now also indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type. (see Section 4.2 Dose and Method of Administration: Behavioural Disturbances in Dementia)

FIRAZYR orphan drug

Evaluation commenced: 29 Jun 2018

Registration decision: 23 Jul 2019

Date registered: 26 Jul 2019

Approval time: 217 working days (255)

icatibant (as acetate)

Shire Australia Pty Ltd

FIRAZYR (solution for injection) is now indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older with C1-esterase-inhibitor deficiency.

TRULICITY

Evaluation commenced: 3 Oct 2018

Registration decision: 19 Jul 2019

Date registered: 23 Jul 2019

Approval time: 158 working days (175 COR-B)

dulaglutide (rch)

Eli Lilly Australia Pty Ltd

TRULICITY (solution for injection) is now also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus:

  • In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 for data with respect to different combinations).

TECENTRIQ orphan drug

Evaluation commenced: 30 Nov 2018

Registration decision: 17 Jul 2019

Date registered: 19 Jul 2019

Approval time: 133 working days (255)

atezolizumab (rch)

Roche Products Pty Ltd

Small cell lung cancer

TECENTRIQ (solution for injection), in combination with carboplatin and etoposide, is now also indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

SYMBICORT TURBUHALER, RILAST TURBUHALER, SYMBICORT RAPIHALER

Evaluation commenced: 31 Aug 2018

Registration decision: 17 Jul 2019

Date registered: 18 Jul 2019

Approval time: 218 working days (255)

budesonide / formoterol fumarate dihydrate

AstraZeneca Pty Ltd

SYMBICORT TURBUHALER, RILAST TURBUHALER, SYMBICORT RAPIHALER (powder for inhalation) are now also indicated in adults and adolescents (12 years and older), for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations (see Section 4.2 Dose and method of administration).

POMALYST

Evaluation commenced: 31 Aug 2018

Registration decision: 10 Jul 2019

Date registered: 12 Jul 2019

Approval time: 175 working days (255)

pomalidomide

Celgene Pty Ltd

POMALYST (capsules), in combination with bortezomib and dexamethasone, is now also indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide.

KEYTRUDA provisional registration

Evaluation commenced: 31 Jul 2018

Registration decision: 11 Jul 2019

Date registered: 11 Jul 2019

Approval time: 214 working days (255)

pembrolizumab

Merck Sharp & Dohme (Australia) Pty Ltd

Microsatellite instability-high cancer
Colorectal

KEYTRUDA® (powder for injection) is now also indicated in adult and paediatric patients for the treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication was approved via the provisional approval pathway, based on objective response rate and response duration in single-arm trials. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.

Non-colorectal

KEYTRUDA® (powder for injection) is now also indicated in adult and paediatric patients for the treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumours that have progressed following prior treatment and when there are no satisfactory alternative treatment options. This indication was approved via the provisional-approval pathway, based on the pooling of data on objective response rate and response duration across multiple different tissue types in a single-arm trial. Sample sizes for individual tissue types were too small to provide data on clinical utility of the MSIH/ dMMR tests for each of the tissue types, individually. The assumption that MSI-H/dMMR status is predictive of the treatment effect of Keytruda for every tissue type has not been verified. Continued approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.

The safety and effectiveness of KEYTRUDA in paediatric patients with MSI-H central nervous system cancers have not been established.

INFLUVAC TETRA

Evaluation commenced: 2 Jul 2018

Registration decision: 19 Jun 2019

Date registered: 3 Jul 2019

Approval time: 201 working days (255)

influenza virus haemagglutinin

Mylan Health Pty Ltd

INFLUVAC TETRA (prefilled syringe) is indicated for the prevention of influenza caused by influenza virus, types A and B. For full details regarding recommendations for influenza vaccination, please refer to the relevant National Immunisation Guidelines.

INFLUVAC TETRA is now indicated in adults and children from 3 years of age and older.

NPLATE orphan drug

Evaluation commenced: 29 Jun 2018

Registration decision: 1 Jul 2019

Date registered: 3 Jul 2019

Approval time: 216 working days (255)

romiplostim (rbe)

Amgen Australia Pty Ltd

NPLATE (powder for injection) is now also indicated for treatment of thrombocytopenia in patients aged 1 year and older with chronic immune (idiopathic) thrombocytopenic purpura (ITP):

  • who are non-splenectomised and have had an inadequate response, or are intolerant, to corticosteroids and immunoglobulins;
  • who are splenectomised and have had an inadequate response to splenectomy.

June 2019

FINOMEL

Evaluation commenced: 2 Feb 2018

Registration decision: 17 Dec 2018

Date registered: 28 Jun 2019

Approval time: 191 working days (255)

animo acid with electrolyte, glucose and lipid emulsion

Baxter Healthcare Pty Ltd

New combination

FINOMEL (intravenous infusion) is indicated for parenteral nutrition in adult patients when oral or enteral nutrition is impossible, insufficient or contraindicated.

ORKAMBI orphan drug

Evaluation commenced: 29 Jun 2018

Registration decision: 19 Jun 2019

Date registered: 21 Jun 2019

Approval time: 221 working days (255)

lumacaftor/ivacaftor

Vertex Pharmaceuticals Australia Pty Ltd

ORKAMBI (granules) is now also indicated for the treatment of cystic fibrosis (CF) in patients age 2 to 5 years who are homozygous for the F508del mutation in the CFTR gene.

LYNPARZA priority review

Evaluation commenced: 16 Jan 2019

Registration decision: 19 Jun 2019

Date registered: 21 Jun 2019

Approval time: 104 working days (255)

olaparib

AstraZeneca Pty Ltd

Ovarian Cancer

LYNPARZA (film coated tablets) is now also indicated as monotherapy for the:

  • maintenance treatment of adult patients with advanced BRCA-mutated (germline or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) to first-line platinum-based chemotherapy. BRCA mutation status should be determined by an experienced laboratory using a validated test method.

GIOTRIF

Evaluation commenced: 2 Aug 2018

Registration decision: 17 Jun 2019

Date registered: 18 Jun 2019

Approval time: 179 working days (255)

afatinib

Boehringer Ingelheim Pty Ltd

GIOTRIF (film coated tablets) is now also indicated as monotherapy for the treatment of patients with locally advanced or metastatic squamous non-small cell carcinoma of the lung progressing on or after platinum-based chemotherapy.

CIMZIA

Evaluation commenced: 3 Apr 2018

Registration decision: 29 May 2019

Date registered: 13 Jun 2019

Approval time: 240 working days (255)

certolizumab pegol

UCB Australia Pty Ltd

Plaque psoriasis

CIMZIA (solution for injection) is now also indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

KALYDECO orphan drug

Evaluation commenced: 29 Jun 2018

Registration decision: 3 Jun 2019

Date registered: 6 Jun 2019

Approval time: 212 working days (255)

ivacaftor

Vertex Pharmaceuticals Australia Pty Ltd

KALYDECO (film-coated tablets, granules) is now also indicated for the treatment of cystic fibrosis (CF) in patients aged 12 months and older who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, and Section 5.1 PHARMACODYNAMIC PROPERTIES).

May 2019

BRIVIACT

Evaluation commenced: 31 May 2018

Registration decision: 21 May 2019

Date registered: 29 May 2019

Approval time: 196 working days (255)

brivaracetam

UCB Australia Pty Ltd

BRIVIACT (tablets and oral solution) are now also indicated as add-on therapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 4 years of age with epilepsy.

CABOMETYX

Evaluation commenced: 2 Jan 2019

Registration decision: 21 May 2019

Date registered: 28 May 2019

Approval time: 74 working days (120)

cabozantinib

Ipsen Pty Ltd

Hepatocellular Carcinoma (HCC)

CABOMETYX (film-coated tablets) is now also indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.

DUPIXENT

Evaluation commenced: 7 Jun 2018

Registration decision: 23 May 2019

Date registered: 28 May 2019

Approval time: 196 working days (255)

dupilumab (rch)

Sanofi-Aventis Australia Pty Ltd

DUPIXENT (solution for injection) is now also indicated as add on maintenance treatment in patients aged 12 years and older with moderate to severe asthma with type 2 inflammation (elevated eosinophils or elevated FeNO).

DUPIXENT is now also indicated as maintenance therapy for oral corticosteroid dependent asthma.

ADACEL

Evaluation commenced: 2 Jul 2018

Registration decision: 14 May 2019

Date registered: 20 May 2019

Approval time: 197 working days (255)

pertussis vaccine-acellular combined with diphtheria and tetanus toxoids (adsorbed)

Sanofi-Aventis Australia Pty Ltd

ADACEL (suspension for injection) may now also be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.

TAFINLAR

Evaluation commenced: 31 May 2018

Registration decision: 13 May 2019

Date registered: 15 May 2019

Approval time: 202 working days (255)

dabrafenib

Novartis Pharmaceuticals Australia Pty Ltd

Anaplastic thyroid cancer (ATC)

TAFINLAR (capsules) in combination with trametinib is now also indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with a BRAF V600 mutation and with no satisfactory locoregional treatment options.

Non-small cell lung cancer (NSCLC)

TAFINLAR in combination with trametinib is now also indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.

MEKINIST

Evaluation commenced: 31 May 2018

Registration decision: 13 May 2019

Date registered: 14 May 2019

Approval time: 202 working days (255)

trametinib

Novartis Pharmaceuticals Australia Pty Ltd

Anaplastic thyroid cancer (ATC)

MEKINIST (film-coated tablet) in combination with dabrafenib is now also indicated for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with a BRAF V600 mutation and with no satisfactory locoregional treatment options.

Non-small cell lung cancer (NSCLC)

MEKINIST in combination with dabrafenib is now also indicated for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.

April 2019

TECENTRIQ

Evaluation commenced: 30 Apr 2018

Registration decision: 12 Apr 2019

Date registered: 26 Apr 2019

Approval time: 196 working days (255)

atezolizumab

Roche Products Pty Ltd

Non-small cell lung cancer

TECENTRIQ, in combination with bevacizumab, paclitaxel and carboplatin, is now also indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, TECENTRIQ, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.

TECENTRIQ as monotherapy is now also indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK-positive NSCLC should also have received targeted therapies before receiving Tecentriq.

TECENTRIQ

Evaluation commenced: 4 Apr 2018

Registration decision: 12 Apr 2019

Date registered: 24 Apr 2019

Approval time: 217 working days (255)

atezolizumab

Roche Products Pty Ltd

Urothelial carcinoma

TECENTRIQ is now also indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who

  • are considered cisplatin ineligible and whose tumours express PD-L1 (PD-L1 stained tumour-infiltrating immune cells [IC] covering ≥ 5% of the tumour area), as determined by a validated test, or
  • are considered ineligible for any other platinum-containing chemotherapy regardless of the level of tumor PD-L1 expression.

ARIXTRA

Evaluation commenced: 30 Nov 2017

Registration decision: 9 Apr 2019

Date registered: 12 Apr 2019

Approval time: 237 working days (255)

fondaparinux sodium

Aspen Pharmacare Australia Pty Ltd

ARIXTRA is now also indicated for the treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (<120 min) invasive management (PCI) in not indicated.

ARIXTRA is now also indicated for the treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed without any form of initial reperfusion therapy.

March 2019

INOmax

Evaluation commenced: 30 Apr 2018

Registration decision: 25 Mar 2019

Date registered: 29 Mar 2019

Approval time: 208 working days (255)

nitric oxide

Ikaria Australia Pty Ltd

INOmax (medicinal gas for inhalation) in conjunction with ventilatory support and other appropriate agents, is now also indicated to selectively decrease pulmonary arterial pressure in patients with perioperative pulmonary hypertension in conjunction with heart surgery.

ACTEMRA

Evaluation commenced: 31 Jan 2019

Registration decision: 22 Mar 2019

Date registered: 28 Mar 2019

Approval time: 36 working days (120 COR-A)

tocilizumab

Roche Products Pty Ltd

ACTEMRA (solution for injection) is now also indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older (IV formulation only).

AFLURIA QUAD, AFLURIA QUAD JUNIOR

Evaluation commenced: 2 Jan 2018

Registration decision: 15 Mar 2019

Date registered: 18 Mar 2019

Approval time: 197 working days (255)

influenza virus haemagglutinin

Seqirus Pty Ltd

For the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine. Afluria Quad vaccine (suspension for injection) is indicated for use in persons aged 3 years and older. Afluria Quad Junior vaccine (suspension for injection) is indicated for use in children aged 6 months to 35 months inclusive. For full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

ARNUITY ELLIPTA

Evaluation commenced: 3 Apr 2018

Registration decision: 8 Mar 2019

Date registered: 14 Mar 2019

Approval time: 200 working days (255)

fluticasone furoate

GlaxoSmithKline Australia Pty Ltd

ARNUITY ELLIPTA (powder for inhalation) is now also indicated for the maintenance treatment of asthma in patients aged 5 years to less than 12 years.

KEYTRUDA priority review

Evaluation commenced: 6 Sep 2018

Registration decision: 5 Mar 2019

Date registered: 8 Mar 2019

Approval time: 124 working days (255)

pembrolizumab

Merck Sharp & Dohme (Australia) Pty Ltd

KEYTRUDA (powder for injection), in combination with carboplatin and either paclitaxel or nab-paclitaxel, is now also indicated for the first-line treatment of patients with metastatic squamous NSCLC.

REVOLADE priority review

Evaluation commenced: 1 Nov 2018

Registration decision: 7 Mar 2019

Date registered: 8 Mar 2019

Approval time: 87 working days (255)

eltrombopag olamine

Novartis Pharmaceuticals Australia Pty Ltd

REVOLADE (film-coated tablet and powder for oral suspension) is now also indicated for the treatment of adult and paediatric patients 2 years and older with severe aplastic anaemia (SAA) for use in combination with standard immunosuppressive therapy (first-line SAA).

February 2019

ZAVICEFTA

Evaluation commenced: 30 Apr 2018

Registration decision: 21 Feb 2019

Date registered: 22 Feb 2019

Approval time: 161 working days (175 COR-B)

avibactam sodium; ceftazidime pentahydrate

Pfizer Australia Pty Ltd

New combination

ZAVICEFTA (powder for injection) is indicated for the treatment of the following infections in adults:

  • Complicated intra-abdominal infection (cIAI), in combination with metronidazole.
  • Complicated urinary tract infection (cUTI), including pyelonephritis.
  • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).

Consideration should be given to official guidance on the appropriate use of antibacterial agents. ZAVICEFTA should be used in combination with an antibacterial agent(s) active against Gram-positive and/or anaerobic pathogens when these are known or suspected to be contributing to the infectious process.

XELJANZ

Evaluation commenced: 31 Jan 2018

Registration decision: 29 Jan 2019

Date registered: 19 Feb 2019

Approval time: 195 working days (255)

tofacitinib citrate

Pfizer Australia Pty Ltd

XELJANZ (film coated tablets) is now also indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy.

KAPANOL

Evaluation commenced: 1 Aug 2017

Registration decision: 6 Feb 2019

Date registered: 14 Feb 2019

Approval time: 218 working days (255)

morphine sulfate pentahydrate

Mayne Pharma International Pty Ltd

KAPANOL (modified release capsules) is indicated for the symptomatic reduction of chronic breathlessness in the palliative care of patients with distressing breathlessness due to severe COPD, cardiac failure, malignancy or other cause. Kapanol should only be used after treatments for the underlying cause(s) of the breathlessness have been optimised and non-pharmacological treatments are not effective. Treatment with Kapanol in this setting should only be initiated by a specialist knowledgeable in its use.

EZETIMIBE LUPIN, EZETIMIBE LAPL, EZETIMIBE GH

Evaluation commenced: 28 Nov 2018

Registration decision: 25 Jan 2019

Date registered: 4 Feb 2019

Approval time: 40 working days (255)

ezetimibe

Lupin Australia Pty Limited

Generic medicine

EZETIMIBE LUPIN, EZETIMIBE LAPL and EZETIMIBE GH (tablets), in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit, is now also indicated for the prevention of cardiovascular disease in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.

DELSTRIGO

Evaluation commenced: 31 Jan 2018

Registration decision: 18 Jan 2019

Date registered: 4 Feb 2019

Approval time: 192 working days (255)

tenofovir disoproxil fumarate; lamivudine; doravirine

Merck Sharp & Dohme (Australia) Pty Ltd

New combination

DELSTRIGO is indicated for the treatment of HIV-1 infection in adults who are antiretroviral therapy (ART)-naïve with no known substitutions associated with resistance to doravirine, lamivudine, or tenofovir.

January 2019

NUCALA orphan drug

Evaluation commenced: 2 Jan 2018

Registration decision: 24 Jan 2019

Date registered: 29 Jan 2019

Approval time: 224 working days (255)

mepolizumab

GlaxoSmithKline Australia Pty Ltd

NUCALA is now also indicated as an add-on treatment for relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) in adult patients aged 18 years and over.

CUBICIN

Evaluation commenced: 31 Jan 2018

Registration decision: 22 Jan 2019

Date registered: 25 Jan 2019

Approval time: 200 working days (255)

daptomycin

Merck Sharp & Dohme (Australia) Pty Ltd

CUBICIN (powder for injection) is now also indicated for:

Staphylococcus aureus Bloodstream Infections (Bacteraemia)

CUBICIN is indicated in paediatric patients (1 to 17 years of age) with Staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. Empiric treatment should be reviewed based on the results of susceptibility testing. Prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of Staphylococcus aureus bacteraemia.

XARELTO

Evaluation commenced: 31 Jan 2018

Registration decision: 24 Dec 2018

Date registered: 11 Jan 2019

Approval time: 184 working days (255)

rivaroxaban

Bayer Australia Ltd

XARELTO (tablets), in combination with aspirin, is now also indicated for the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD).

CIZIGO , CIZINATE, CIZERE

Evaluation commenced: 31 May 2017

Registration decision: 24 Dec 2018

Date registered: 8 Jan 2019

Approval time: 246 working days (255)

cinnarizine/dimenhydrinate

Southern Cross Pharma Pty Ltd

New combination

CIZIGO, CIZINATE, CIZERE (fixed-dose combination tablets) are indicated for the short-term, symptomatic treatment of vertigo of various causes, in adults who have not responded to alternative treatments.