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

6 October 2020

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, 2020

Previous years

2019 2018 2017 2016

September 2020

KEYTRUDA

Evaluation commenced: 2 Dec 2019

Registration decision: 22 Sep 2020

Date registered: 28 Sep 2020

Approval time: 161 working days (255)

pembrolizumab

Merck Sharp & Dohme (Australia) Pty Ltd

Head and Neck Squamous Cell Cancer (HNSCC)

KEYTRUDA® (powder for injection, concentrated solution for injection), as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is now also indicated for the first-line treatment of patients with metastatic or unresectable recurrent HNSCC, and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.

KEYTRUDA® is now also indicated as monotherapy for the treatment of patients with metastatic or unresectable recurrent HNSCC with disease progression on or after platinum-containing chemotherapy and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.

COSENTYX

Evaluation commenced: 4 Dec 2019

Registration decision: 10 Sep 2020

Date registered: 17 Sep 2020

Approval time: 146 working days (255)

secukinumab

Novartis Pharmaceuticals Australia Pty Ltd

COSENTYX (powder for injection; 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 C-reactive protein (CRP) and/or MRI change, who have had an inadequate response to, or are intolerant to, NSAIDs.

TECENTRIQ orphan drugpriority review

Evaluation commenced: 2 Mar 2020

Registration decision: 28 Aug 2020

Date registered: 8 Sep 2020

Approval time: 124 working days (255)

atezolizumab

Roche Products Pty Ltd

Hepatocellular carcinoma

TECENTRIQ (concentrated solution for injection), in combination with bevacizumab, is now also indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

July 2020

ATECTURA BREEZHALER

Evaluation commenced: 31 Jul 2019

Registration decision: 16 Jul 2020

Date registered: 21 Jul 2020

Approval time: 194 working days (255)

indacaterol acetate; mometasone furoate

Novartis Pharmaceuticals Australia Pty Ltd

New Combination

ATECTURA BREEZHALER (microgram powder for inhalation in hard capsule with inhaler) is indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older where use of a combination of long-acting beta2-agonist and inhaled corticosteroid is appropriate:

  • patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonists or
  • patients not adequately controlled with long-acting beta2-agonists and low dose of inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonists.

DELSTRIGO

Evaluation commenced: 31 May 2019

Registration decision: 13 Jul 2020

Date registered: 21 Jul 2020

Approval time: 197 working days (255)

doravirine; lamivudine; tenofovir disoproxil fumarate

Merck Sharp & Dohme (Australia) Pty Ltd

DELSTRIGO (film coated tablet) is now indicated for the treatment of HIV-1 infection in adult patients:

  • With no prior antiretroviral history, OR
  • To replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine, lamivudine, or tenofovir.

DYSPORT A

Evaluation commenced: 31 Jul 2019

Registration decision: 14 Jul 2020

Date registered: 21 Jul 2020

Approval time: 199 working days (255)

clostridium botulinum type a toxin haemagglutinin complex

Ipsen Pty Ltd

DYSPORT (powder for injection) is now also indicated for symptomatic treatment of focal spasticity of upper limbs in children aged 2 years and older.

PIFELTRO

Evaluation commenced: 31 May 2019

Registration decision: 13 Jul 2020

Date registered: 21 Jul 2020

Approval time: 197 working days (255)

doravirine

Merck Sharp & Dohme (Australia) Pty Ltd

PIFELTRO (film coated tablet) is now indicated, in combination with other antiretroviral medicinal products, for the treatment of HIV-1 infection in adult patients:

  • with no prior antiretroviral treatment history, OR
  • to replace the current antiretroviral regimen in those who are Virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

TRULICITY

Evaluation commenced: 30 Sep 2019

Registration decision: 14 Jul 2020

Date registered: 15 Jul 2020

Approval time: 158 working days (255)

dulaglutide

Eli Lilly Australia Pty Ltd

Type 2 Diabetes Mellitus: reduction in risk of major adverse cardiovascular events

TRULICITY (solution for injection) is now also indicated as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have:

  • established cardiovascular disease or
  • multiple cardiovascular risk factors.

WINGLORE, YERVOY

Evaluation commenced: 31 Mar 2020

Registration decision: 9 Jul 2020

Date registered: 13 Jul 2020

Approval time: 68 working days (255)

ipilimumab

Bristol-Myers Squibb Australia Pty Ltd

Non-Small Cell Lung Cancer (NSCLC)

WINGLORE, YERVOY (concentrated solution for injection), in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is now also indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations.

OPDIVO

Evaluation commenced: 31 Mar 2020

Registration decision: 9 Jul 2020

Date registered: 13 Jul 2020

Approval time: 68 working days (255)

nivolumab

Bristol-Myers Squibb Australia Pty Ltd

Non-Small Cell Lung Cancer (NSCLC)

OPDIVO (concentrated solution for injection), in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is now also indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations.

FENOFIBRATE SANDOZ

Evaluation commenced: 13 Dec 2019

Registration decision: 5 Feb 2020

Date registered: 7 Jul 2020

Approval time: 32 working days (45)

fenofibrate

Sandoz Pty Ltd

Generic Medicine

FENOFIBRATE SANDOZ (film coated tablet) is now also indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy.

FENOFIBRATE SANDOZ does not replace the appropriate control of blood pressure, blood glucose and blood lipids in reducing the progression of diabetic retinopathy.

SOLIRIS orphan drug

Evaluation commenced: 2 Dec 2019

Registration decision: 26 Jun 2020

Date registered: 1 Jul 2020

Approval time: 115 working days (255)

eculizumab

Alexion Pharmaceuticals Australasia Pty Ltd

SOLIRIS (intravenous infusion) is indicated for the treatment of patients with:

  • Paroxysmal Nocturnal Haemoglobinuria (PNH) to reduce haemolysis.
  • atypical Haemolytic Uraemic Syndrome (aHUS).
  • Adult patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody-positive.

SOLIRIS is not intended for acute treatment of a NMOSD relapse.

June 2020

ADACEL POLIO

Evaluation commenced: 30 Apr 2020

Registration decision: 26 Jun 2020

Date registered: 30 Jun 2020

Approval time: 40 working days (255)

diphtheria toxoid; pertactin; pertussis filamentous haemagglutinin; pertussis fimbriae 2 + 3; pertussis toxoid; poliovirus; tetanus toxoid

Sanofi-Aventis Australia Pty Ltd

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

SPRYCEL

Evaluation commenced: 16 Jul 2019

Registration decision: 25 Jun 2020

Date registered: 29 Jun 2020

Approval time: 213 working days (255)

dasatinib

Bristol-Myers Squibb Australia Pty Ltd

SPRYCEL (film-coated tablet) is now also indicated for the treatment of paediatric patients with:

  • Ph+ CML in the chronic phase.
  • newly diagnosed Ph+ ALL in combination with chemotherapy.

TRIMBOW

Evaluation commenced: 10 May 2019

Registration decision: 18 Jun 2020

Date registered: 24 Jun 2020

Approval time: 155 working days (255)

beclometasone dipropionate; formoterol (eformoterol) fumarate dihydrate; glycopyrronium bromide (glycopyrrolate)

Emerge Health Pty Ltd

New Combination

TRIMBOW (pressurised inhalation solution) is indicated for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA) or a combination of a LABA and a long-acting muscarinic antagonist (LAMA).

TOUJEO

Evaluation commenced: 2 Sep 2019

Registration decision: 12 Jun 2020

Date registered: 22 Jun 2020

Approval time: 170 working days (255)

insulin glargine

Sanofi-Aventis Australia Pty Ltd

TOUJEO (solution for injection) is now also indicated for the treatment of diabetes mellitus in adolescents and children 6 years of age and older.

KEYTRUDA

Evaluation commenced: 31 Jul 2019

Registration decision: 2 Jun 2020

Date registered: 12 Jun 2020

Approval time: 173 working days (255)

pembrolizumab

Merck Sharp & Dohme (Australia) Pty Ltd

Renal Cell Carcinoma

KEYTRUDA® (concentrated injection; powder for injection) in combination with axitinib, is now also indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

May 2020

REVESTIVE orphan drug

Evaluation commenced: 31 May 2019

Registration decision: 26 May 2020

Date registered: 26 May 2020

Approval time: 203 working days (255)

teduglutide

Shire Australia Pty Ltd

REVESTIVE (powder for solution for injection) is now also indicated for the treatment of paediatric patients 2 year of age and above with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

SLENYTO

Evaluation commenced: 31 Jul 2019

Registration decision: 20 May 2020

Date registered: 22 May 2020

Approval time: 171 working days (175)

melatonin

RAD Data Australia Pty Ltd

SLENYTO (modified release tablet) is now indicated for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.

BIRESP SPIROMAX, DUORESP SPIROMAX

Evaluation commenced: 19 Mar 2020

Registration decision: 30 Apr 2020

Date registered: 20 May 2020

Approval time: 28 working days (45)

budesonide; formoterol (eformoterol) fumarate dihydrate

Teva Pharma Australia Pty Ltd

Generic medicine
Asthma

BIRESP SPIROMAX, DUORESP SPIROMAX (powder for inhalation) are now also indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk and exacerbations (see Section 4.2 Dose and method of administration).

BIRESP SPIROMAX, DUORESP SPIROMAX are not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.

STELARA

Evaluation commenced: 1 May 2019

Registration decision: 14 May 2020

Date registered: 19 May 2020

Approval time: 214 working days (255)

ustekinumab

Janssen-Cilag Pty Ltd

Ulcerative colitis

STELARA (solution for injection) is now also indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

LIPIODOL

Evaluation commenced: 30 Apr 2019

Registration decision: 14 May 2020

Date registered: 18 May 2020

Approval time: 208 working days (255)

iodised oil

Guerbet Australia Pty Ltd

In interventional radiology

LIPIODOL (solution for injection) is now also indicated as an imaging agent for visualisation and localisation during Trans-Arterial Chemo-Embolisation (TACE) of hepatocellular carcinoma (HCC) at intermediate stage in adults (see section 4.3 -Contraindications and Section 4.4 Special Warnings and Precautions for Use).

BAVENCIO

Evaluation commenced: 1 Jul 2019

Registration decision: 4 May 2020

Date registered: 6 May 2020

Approval time: 190 working days (255)

avelumab

Merck Healthcare Pty Ltd

BAVENCIO (concentrated solution for injection) in combination with axitinib is now also indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

VENCLEXTA, VENCLEXTA STARTING PACK

Evaluation commenced: 30 Apr 2019

Registration decision: 30 Apr 2020

Date registered: 5 May 2020

Approval time: 222 working days (255)

venetoclax

Abbvie Pty Ltd

Chronic Lymphocytic Leukaemia / Small Lymphocytic Lymphoma

VENCLEXTA (film coated tablet) in combination with obinutuzumab is now also indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who are considered unfit or unsuitable for chemo-immunotherapy.

April 2020

DARZALEX, JANSSEN DARATUMUMAB

Evaluation commenced: 1 Jul 2019

Registration decision: 29 Apr 2020

Date registered: 30 Apr 2020

Approval time: 186 working days (255)

daratumumab

Janssen-Cilag Pty Ltd

DARZALEX (concentrated solution for injection) is now also indicated for the treatment of patients:

  • with newly diagnosed multiple myeloma:
    • who are eligible for autologous stem cell transplant. For use in combination with:
      • bortezomib, thalidomide, and dexamethasone.
  • who are ineligible for autologous stem cell transplant. For use in combination with:
    • bortezomib, melphalan and prednisone, or
    • lenalidomide and dexamethasone.
  • with multiple myeloma who have received:
    • at least one prior therapy. For use in combination with:
      • bortezomib and dexamethasone, or
      • lenalidomide and dexamethasone.
    • at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent. For use as:
      • monotherapy.

ADCETRIS

Evaluation commenced: 2 Sep 2019

Registration decision: 24 Apr 2020

Date registered: 30 Apr 2020

Approval time: 146 working days (255)

brentuximab vedotin

Takeda Pharmaceuticals Australia Pty Ltd

Peripheral T-cell lymphoma

ADCETRIS (powder for injection) is now also indicated for the treatment of adult patients with previously untreated CD30+ peripheral T-cell lymphoma (PTCL) in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) (see 5.1 Pharmacodynamic Propertues, Clinical Trials).

ESCITALOPRAM GH

Evaluation commenced: 27 Feb 2020

Registration decision: 3 Apr 2020

Date registered: 24 Apr 2020

Approval time: 18 working days (45)

escitalopram oxalate

Lupin Australia Pty Limited

Generic medicine

ESCITALOPRAM GH (film coated tablets) is now also indicated for:

  • Treatment of social anxiety disorder (social phobia).
  • Treatment of generalised anxiety disorder.

FORXIGA

Evaluation commenced: 31 May 2019

Registration decision: 15 Apr 2020

Date registered: 17 Apr 2020

Approval time: 184 working days (255)

dapagliflozin propanediol monohydrate

AstraZeneca Pty Ltd

Prevention of hospitalisation for heart failure

FORXIGA (film coated tablets) is now also indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure (see section 5.1 Pharmacodynamic properties - Clinical trials).

XIGDUO XR

Evaluation commenced: 31 May 2019

Registration decision: 15 Apr 2020

Date registered: 17 Apr 2020

Approval time: 184 working days (255)

dapagliflozin propanediol monohydrate; metformin hydrochloride

AstraZeneca Pty Ltd

Prevention of hospitalisation for heart failure

XIGDUO XR (modified release tablets) is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure.

ZERBAXA

Evaluation commenced: 4 Mar 2019

Registration decision: 31 Mar 2020

Date registered: 7 Apr 2020

Approval time: 169 working days (255)

ceftolozane sulfate; tazobactam sodium

Merck Sharp & Dohme (Australia) Pty Ltd

ZERBAXA (powder for injection) is now also indicated for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia (VAP) infections in adults suspected or proven to be caused by designated susceptible microorganisms.

OFEV, VARGATEF orphan drug

Evaluation commenced: 31 May 2019

Registration decision: 1 Apr 2020

Date registered: 3 Apr 2020

Approval time: 170 working days (255)

nintedanib esilate

Boehringer Ingelheim Pty Ltd

OFEV, VARGATEF (soft capsules) are now also indicated for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

LUCENTIS

Evaluation commenced: 5 Mar 2019

Registration decision: 27 Mar 2020

Date registered: 2 Apr 2020

Approval time: 196 working days (255)

ranibizumab (rbe)

Novartis Pharmaceuticals Australia Pty Ltd

LUCENTIS (solution for injection) is now also indicated in adults for the treatment of proliferative diabetic retinopathy (PDR).

March 2020

ACTEMRA

Evaluation commenced: 22 Feb 2019

Registration decision: 18 Mar 2020

Date registered: 24 Mar 2020

Approval time: 242 working days (255)

tocilizumab

Roche Products Pty Ltd

Subcutaneous formulation

ACTEMRA (solution for injection) is now also indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older.

ACTEMRA IV and SC can be given alone or in combination with methotrexate (MTX).

AKYNZEO IV

Evaluation commenced: 3 Jun 2019

Registration decision: 13 Mar 2020

Date registered: 13 Mar 2020

Approval time: 172 working days (255)

fosnetupitant chloride hydrochloride

Mundipharma Pty Ltd

New Combination

AKYNZEO IV (powder for injection) is indicated for:

  • The prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.
  • The prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

FIASP, FIASP FLEXTOUCH, FIASP PENFILL

Evaluation commenced: 1 Apr 2019

Registration decision: 11 Mar 2020

Date registered: 13 Mar 2020

Approval time: 190 working days (255)

insulin aspart (rys)

Novo Nordisk Pharmaceuticals Pty Ltd

FIASP, FIASP FLEXTOUCH, FIASP PENFILL (solution for injection) is now also indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

RYZODEG 70/30 FLEXTOUCH, RYZODEG 70/30 PENFILL

Evaluation commenced: 2 Jan 2019

Registration decision: 10 Mar 2020

Date registered: 11 Mar 2020

Approval time: 250 working days (255)

insulin degludec (rys), insulin aspart (rys)

Novo Nordisk Pharmaceuticals Pty Ltd

RYZODEG 70/30 FLEXTOUCH, RYZODEG 70/30 PENFILL (solution for injection) are now also indicated for use in diabetes mellitus in patients aged 6 years and older.

TALTZ

Evaluation commenced: 1 Apr 2019

Registration decision: 6 Mar 2020

Date registered: 11 Mar 2020

Approval time: 159 working days (255)

ixekizumab

Eli Lilly Australia Pty Ltd

Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)

TALTZ (solution for injection) is now also indicated for the treatment of active ankylosing spondylitis in adult patients.

February 2020

TECENTRIQ

Evaluation commenced: 1 Apr 2019

Registration decision: 14 Feb 2020

Date registered: 19 Feb 2020

Approval time: 194 working days (255)

atezolizumab

Roche Products Pty Ltd

TECENTRIQ (concentrated solution for injection), in combination with nab-paclitaxel and carboplatin, is now also indicated for first-line treatment of patients with metastatic non-squamous NSCLC who do not have tumour EGFR or ALK genomic aberrations.

VENCLEXTA, VENCLEXTA STARTING PACK orphan drugprovisional registration

Evaluation commenced: 31 Oct 2019

Registration decision: 11 Feb 2020

Date registered: 14 Feb 2020

Approval time: 67 working days (255)

venetoclax

Abbvie Pty Ltd

Acute Myeloid Leukaemia

VENCLEXTA (film-coated tablet), as part of combination therapy, is now also indicated for the treatment of newly diagnosed adult patients with Acute Myeloid Leukaemia (AML) who are ineligible for intensive chemotherapy.

This medicine has provisional approval in Australia for the treatment of newly diagnosed patients with AML who are ineligible for intensive chemotherapy. The decision to approve this indication has been made on the basis of interim data (overall response rate and duration of response). Continued approval of this indication depends on verification and description of benefit in confirmatory trials.

FOSTAIR

Evaluation commenced: 31 Oct 2018

Registration decision: 20 Jan 2020

Date registered: 12 Feb 2020

Approval time: 194 working days (255)

beclometasone dipropionate; formoterol (eformoterol) fumarate dihydrate

Emerge Health Pty Ltd

New Combination
Asthma

FOSTAIR (solution for inhalation) is indicated in adults (18 years and older) in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:

  • patients not adequately controlled with inhaled corticosteroids (ICS) and 'as needed' inhaled rapid-acting beta2-agonist or
  • patients already adequately controlled on both ICS and long-acting beta2-agonists (LABA).
COPD

Symptomatic treatment of adults with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

VENCLEXTA, VENCLEXTA STARTING PACK orphan drugprovisional registration

Evaluation commenced: 31 Jan 2019

Registration decision: 3 Feb 2020

Date registered: 11 Feb 2020

Approval time: 227 working days (255)

venetoclax

Abbvie Pty Ltd

Acute Myeloid Leukaemia

VENCLEXTA (film-coated tablet), as part of combination therapy, is now also indicated for the treatment of newly diagnosed adult patients with Acute Myeloid Leukaemia (AML) who are ineligible for intensive chemotherapy.

This medicine has provisional approval in Australia for the treatment of newly diagnosed patients with AML who are ineligible for intensive chemotherapy. The decision to approve this indication has been made on the basis of interim data (overall response rate and duration of response). Continued approval of this indication depends on verification and description of benefit in confirmatory trials.

HADLIMA

Evaluation commenced: 31 May 2019

Registration decision: 28 Jan 2020

Date registered: 6 Feb 2020

Approval time: 164 working days (255)

adalimumab

Samsung Bioepis AU Pty Ltd

Juvenile Idiopathic Arthritis
Polyarticular Juvenile Idiopathic Arthritis

HADLIMA (solution for injection) in combination with methotrexate is now also indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying antirheumatic drugs (DMARDs). HADLIMA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Enthesitis-Related Arthritis

HADLIMA is now also indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.

Psoriatic Arthritis

HADLIMA is now also indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.

Ankylosing Spondylitis

HADLIMA is now also indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Crohn's Disease in Adults and Children (6 years and older)

HADLIMA is now also indicated for the treatment of moderate to severe Crohn's disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;

  • who have had an inadequate response to conventional therapies or,
  • who have lost response to or are intolerant to infliximab.
Ulcerative Colitis

HADLIMA is now also indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time.

Psoriasis in Adults and Children

HADLIMA is now also indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. HADLIMA is now also indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.

Hidradenitis Suppurativa in Adults and Adolescents (from 12 years of age)

HADLIMA is now also indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.

Uveitis

HADLIMA is now also indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

January 2020

CEQUA

Evaluation commenced: 28 Feb 2019

Registration decision: 28 Jan 2020

Date registered: 31 Jan 2020

Approval time: 203 working days (255)

ciclosporin

Sun Pharma ANZ Pty Ltd

CEQUA (eye drops) is indicated to increase tear production in patients with moderate to severe keratoconjunctivitis sicca (dry eye) where prior use of artificial tears has not been sufficient.