Prescription medicines: new or extended uses, or new combinations of registered medicines, 2017

Related information

26 March 2018

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' and 'extended uses'. A new use is where an existing medicine is approved for an additional therapeutic use. An extended use is where an existing medicine is approved to treat a broader range of patients, e.g. wider age range.These types of changes are called 'extension of indications'. A 'new combination' is where two or more previously registered medicines are combined into a single product.

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

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

The trade name, sponsor and active ingredient 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 new or extended indications. For a full list of registered indications for each product please refer to the Product Information database.

2017 summary

cover of report

The Prescription medicines and biologicals: TGA annual summary 2017 publication provides details of all NCEs registered in 2017, as well as new or extended uses for existing medicines, priority determinations and orphan drug designations, biologicals, generic prescription medicines, biosimilar prescription medicines and Australian Public Assessment Reports (AusPARs).

Registration of new or extended uses of registered medicines, 2017

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. This timeframe is 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.

All products were approved within the statutory 255 working day period.


symbol denoting an orphan drug

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


2017: Dec Nov Oct Sep Aug Jul Jun May Apr Mar Feb Jan

December 2017

STIVARGA orphan drug

Evaluation commenced: 28 February 2017

Registration decision: 18 December 2017

Entry onto ARTG: 21 December 2017

Approval time: 179 working days

regorafenib

Bayer Australia Ltd

Stivarga is now also indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

XALKORI orphan drug

Evaluation commenced: 3 January 2017

Registration decision: 12 December 2017

Entry onto ARTG: 13 December 2017

Approval time: 214 working days

crizotinib

Pfizer Australia Pty Ltd

Xalkori is now also indicated for the treatment of patients with ROS1-positive advanced non-small cell lung cancer (NSCLC).

MAVENCLAD

Evaluation commenced: 31 January 2017

Registration decision: 5 December 2017

Entry onto ARTG: 11 December 2017

Approval time: 176 working days

cladribine

Merck Serono Australia Pty Ltd

Mavenclad is now also indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of clinical relapses and to delay the progression of physical disability. Following completion of the 2 treatment courses, no further treatment is required in years 3 and 4. Re-initiation of therapy after year 4 has not been studied.

ABILIFY MAINTENA

Evaluation commenced: 31 March 2017

Registration decision: 5 December 2017

Entry onto ARTG: 5 December 2017

Approval time: 130 working days

aripiprazole as monohydrate

Lundbeck Australia Pty Ltd

Abilify Maintena is now also indicated for maintenance treatment to prevent the recurrence of manic or mixed episodes of bipolar I disorder in adult patients as monotherapy.

GAZYVA

Evaluation commenced: 30 November 2016

Registration decision: 16 November 2017

Entry onto ARTG: 5 December 2017

Approval time: 219 working days

obinutuzumab

Roche Products Pty Ltd

Gazyva, in combination with chemotherapy followed by Gazyva maintenance, is now also indicated for the treatment of patients with previously untreated advanced follicular lymphoma.

November 2017

TASIGNA

Evaluation commenced: 30 November 2016

Registration decision: 16 November 2017

Entry onto ARTG: 24 November 2017

Approval time: 198 working days

nilotinib

Novartis Pharmaceuticals Australia Pty Ltd

Tasigna is indicated for the treatment of adult patients with:

  • newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (CML) in chronic phase;
  • chronic phase and accelerated phase Philadelphia chromosome positive CML that is resistant to or intolerant of prior therapy including imatinib.

AVASTIN

Evaluation commenced: 30 November 2016

Registration decision: 16 November 2017

Entry onto ARTG: 23 November 2017

Approval time: 223 working days

bevacizumab

Roche Products Pty Limited

Avastin, in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is now also indicated for the treatment of platinum-sensitive epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer.

ACTEMRA

Evaluation commenced: 3 March 2017

Registration decision: 14 November 2017

Entry onto ARTG: 16 November 2017

Approval time: 194 working days

tocilizumab (rch)

Roche Products Pty Limited

Actemra is now also indicated for the treatment of giant cell arteritis (GCA) in adult patients.

October 2017

SOLIQUA

Evaluation commenced: 30 November 2016

Registration decision: 23 October 2017

Entry onto ARTG: 27 October 2017

Approval time: 178 working days

insulin glargine (rbe) and lixisenatide

Sanofi-Aventis Australia Pty Ltd

Soliqua is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin.

ELIGARD

Evaluation commenced: 30 September 2016

Registration decision: 6 October 2017

Entry onto ARTG: 12 October 2017

Approval time: 221 working days

leuprorelin

Tolmar Australia Pty Ltd

Eligard is now also indicated for the treatment of high-risk localised and locally advanced hormone-dependent prostate cancer in combination with radiotherapy.

September 2017

PRALUENT

Evaluation commenced: 31 August 2016

Registration decision: 12 September 2017

Entry onto ARTG: 26 September 2017

Approval time: 218 working days

alirocumab (rch)

Sanofi Aventis Australia Pty Ltd

Praluent is indicated as an adjunct to diet and exercise to reduce LDL-cholesterol (LDL-C) in adults with one or more of: heterozygous familial hypercholesterolaemia, clinical atherosclerotic cardiovascular disease, or hypercholesterolemia with high or 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 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.

KEYTRUDA

Evaluation commenced: 31 October 2016

Registration decision: 1 September 2017

Entry onto ARTG: 7 September 2017

Approval time: 195 working days

pembrolizumab (rch)

Merck Sharp & Dohme (Australia) Pty Limited

Keytruda as monotherapy is now also indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin Lymphoma (cHL): 1. following autologous stem cell transplant (ASCT) or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.

ULTIBRO BREEZHALER 110/50

Evaluation commenced: 31 October 2016

Registration decision: 4 September 2017

Entry onto ARTG: 6 September 2017

Approval time: 193 working days

indacaterol (as maleate) / glycopyrronium (as bromide)

Novartis Pharmaceuticals Australia Pty Ltd

Ultibro Breezhaler 110/50 is now also indicated for the reduction of exacerbations of chronic obstructive pulmonary disease (COPD) in patients with a history of exacerbations.

August 2017

FRAXIPARINE

Evaluation commenced: 30 September 2016

Registration decision: 28 August 2017

Entry onto ARTG: 31 August 2017

Approval time: 188 working days

nadroparin calcium

Aspen Pharmacare Australia Pty Ltd

Fraxiparine is now also indicated for the prophylaxis of venous thromboembolism in high-risk medical patients who are immobilised due to acute illness or hospitalised in an intensive care unit.

ALOXI

Evaluation commenced: 31 October 2016

Registration decision: 14 August 2017

Entry onto ARTG: 22 August 2017

Approval time: 161 working days

palonosetron as hydrochloride

Mundipharma Pty Ltd

Aloxi is now also indicated for prevention of post-operative nausea and vomiting (PONV) for up to 24 hours following surgery.

LUCENTIS

Evaluation commenced: 30 November 2016

Registration decision: 14 August 2017

Entry onto ARTG: 22 August 2017

Approval time: 154 working days

ranibizumab (rbe)

Novartis Pharmaceuticals Australia Pty Ltd

Lucentis is now also indicated in adults for the treatment of visual impairment due to choroidal neovascularisation.

July 2017

BLINCYTO

Evaluation commenced: 31 August 2016

Registration decision: 19 July 2017

Entry onto ARTG: 28 July 2017

Approval time: 199 working days

blinatumomab

Amgen Australia Pty Ltd

Blincyto is now also indicated for the treatment of paediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

LENVIMA

Evaluation commenced: 31 August 2016

Registration decision: 26 July 2017

Entry onto ARTG: 27 July 2017

Approval time: 181 working days

lenvatinib

Eisai Australia Pty Limited

Lenvima is now also indicated in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma whose disease has progressed following one prior vascular endothelial growth factor targeted therapy.

OPDIVO

Evaluation commenced: 2 September 2016

Registration decision: 7 July 2017

Entry onto ARTG: 11 July 2017

Approval time: 189 working days

nivolumab

Bristol-Myers Squibb Australia Pty Ltd

Opdivo as monotherapy is now also indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum based therapy.

TRAJENTAMET

Evaluation commenced: 29 July 2016

Registration decision: 28 June 2017

Entry onto ARTG: 6 July 2017

Approval time: 188 working days

linagliptin / metformin hydrochloride

Boehringer Ingelheim Pty Ltd

Trajentamet is now also indicated in combination with a sodium-dependent glucose co-transporter-2 (SGLT2) inhibitor (i.e. triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximum tolerated dose of metformin and an SGLT2 inhibitor.

TRAJENTA

Evaluation commenced: 29 July 2016

Registration decision: 28 June 2017

Entry onto ARTG: 6 July 2017

Approval time: 188 working days

linagliptin

Boehringer Ingelheim Pty Ltd

Trajenta is now also indicated in adult patients with type 2 diabetes mellitus to improve glycaemic control in conjunction with diet and exercise, as add on to metformin plus a sodium-dependent glucose co-transporter-2 (SGLT2) inhibitor.

MENVEO

Evaluation commenced: 14 February 2017

Registration decision: 3 July 2017

Entry onto ARTG: 5 July 2017

Approval time: 85 working days

meningococcal (Groups A, C, W-135 and Y) oligosaccharide CRM197 conjugate vaccines

GlaxoSmithKline Australia Pty Ltd

Menveo is now also indicated for active immunisation of infants and children (from 2 months of age), adolescents and adults to prevent invasive disease caused by Neisseria meningitidis serogroups A, C, W135 and Y.

June 2017

OZURDEX

Evaluation commenced: 29 April 2016

Registration decision: 6 June 2017

Entry onto ARTG: 16 June 2017

Approval time: 235 working days

dexamethasone

Allergan Australia Pty Ltd

Ozurdex is now also indicated for the treatment of macular oedema due to Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO), and also indicated for non-infectious uveitis affecting the posterior segment of the eye.

XELJANZ

Evaluation commenced: 6 June 2016

Registration decision: 1 June 2017

Entry onto ARTG: 6 June 2017

Approval time: 193 working days

tofacitinib (as citrate)

Pfizer Australia

Xeljanz is now also indicated for the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to methotrexate. Xeljanz can be used alone or in combination with nonbiological DMARDs, including methotrexate.

CEREZYME orphan drug

Evaluation commenced: 10 June 2016

Registration decision: 25 May 2017

Entry onto ARTG: 6 June 2017

Approval time: 185 working days

imiglucerase-rch

Sanofi-Aventis Australia Pty Ltd

Cerezyme is now also indicated for long-term enzyme replacement therapy for patients with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease.

May 2017

OPDIVO

Evaluation commenced: 31 May 2016

Registration decision: 26 May 2017

Entry onto ARTG: 30 May 2017

Approval time: 203 working days

nivolumab

Bristol-Myers Squibb Aust Pty Ltd

Opdivo, as monotherapy, is now also indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant and treatment with brentuximab vedotin.

ATOZET/ZETEZE

Evaluation commenced: 29 February 2016

Registration decision: 19 May 2017

Entry onto ARTG: 24 May 2017

Approval time: 192 working days

ezetimibe and atorvastatin

Merck Sharp & Dohme (Australia) Pty Limited

Atozet/Zeteze is now also indicated in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of atorvastatin and in need of additional lowering of low-density lipoprotein cholesterol (LDL-C) in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.

April 2017

JARDIAMET

Evaluation commenced: 29 April 2016

Registration decision: 26 April 2017

Entry onto ARTG: 28 April 2017

Approval time: 214 working days

empagliflozin / metformin hydrochloride

Boehringer Ingelheim Pty Ltd

Empagliflozin is now also indicated in adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death. To prevent cardiovascular deaths, empagliflozin should be used in conjunction with other measures to reduce cardiovascular risk in line with the current standard of care.

VIEKIRA PAK-RBV

Evaluation commenced: 29 February 2016

Registration decision: 21 March 2017

Entry onto ARTG: 21 April 2017

Approval time: 230 working days

paritaprevir/ritonavir/ombitasvir & dasabuvir & ribavirin

AbbVie Pty Ltd

For the treatment of genotype 1 chronic hepatitis C infection, including patients with compensated cirrhosis. Duration of therapy and addition of ribavirin are dependent on patient population.

VIEKIRA PAK

Evaluation commenced: 29 February 2016

Registration decision: 21 March 2017

Entry onto ARTG: 21 April 2017

Approval time: 230 working days

paritaprevir/ritonavir/ombitasvir & dasabuvir

AbbVie Pty Ltd

For the treatment of genotype 1 chronic hepatitis C infection, including patients with compensated cirrhosis. Duration of therapy and addition of ribavirin are dependent on patient population.

March 2017

JINARC

Evaluation commenced: 29 February 2016

Registration decision: 10 March 2017

Entry onto ARTG: 24 March 2017

Approval time: 225 working days

tolvaptan

Otsuka Australia Pharmaceutical Pty Ltd

To slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with chronic kidney disease (CKD) stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.

KEYTRUDA

Evaluation commenced: 30 June 2016

Registration decision: 20 March 2017

Entry onto ARTG: 21 March 2017

Approval time: 163 working days

pembrolizumab (rch)

Merck Sharp & Dohme (Australia) Pty Limited

For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This indication is approved based on overall response rate and duration of response. Improvements in overall survival, progression-free survival or health-related quality of life have not been established.

PEDEA orphan drug

Evaluation commenced: 31 March 2016

Registration decision: 8 March 2017

Entry onto ARTG: 14 March 2017

Approval time: 197 working days

ibuprofen

Emerge Health Pty Ltd

For the treatment of haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.

EPIDUO FORTE

Evaluation commenced: 31 March 2016

Registration decision: 2 March 2017

Entry onto ARTG: 10 March 2017

Approval time: 193 working days

adapalene / benzoyl peroxide

Galderma Australia Pty Ltd

For the cutaneous treatment of acne vulgaris, when comedones, numerous papules and pustules are present in patients 12 years of age and older and the condition has not responded to first line treatment.

KEYTRUDA

Evaluation commenced: 30 September 2016

Registration decision: 3 March 2017

Entry onto ARTG: 7 March 2017

Approval time: 106 working days

pembrolizumab

Merck Sharp & Dohme (Australia) Pty Limited

For the treatment of patients with advanced non-small cell lung carcinoma (NSCLC) whose tumours express programmed death-ligand 1 (PD-L1) with a ≥1% tumour proportion score (TPS) as determined by a validated test and who have received platinum-containing chemotherapy. Patients with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations should have received prior therapy for these aberrations prior to receiving Keytruda.

KEYTRUDA

Evaluation commenced: 1 April 2016

Registration decision: 3 March 2017

Entry onto ARTG: 3 March 2017

Approval time: 212 working days

pembrolizumab

Merck Sharp & Dohme (Australia) Pty Limited

For the first-line treatment of patients with metastatic non-small cell lung carcinoma (NSCLC) whose tumours express programmed death-ligand 1 (PD-L1) with a ≥50% tumour proportion score (TPS) as determined by a validated test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.

STELARA

Evaluation commenced: 31 March 2016

Registration decision: 27 February 2017

Entry onto ARTG: 1 March 2017

Approval time: 189 working days

ustekinumab

Janssen-Cilag Pty Ltd

For the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response, were intolerant to conventional therapy or a TNF alpha antagonist or have medical contraindications to such therapies.

February 2017

VEMLIDY

Evaluation commenced: 29 April 2016

Registration decision: 21 February 2017

Entry onto ARTG: 22 February 2017

Approval time: 185 working days

tenofovir alafenamide (as fumarate)

Gilead Sciences Pty Ltd

For the treatment of chronic hepatitis B in adults.

ZYDELIG

Evaluation commenced: 30 September 2015

Registration decision: 1 February 2017

Entry onto ARTG: 10 February 2017

Approval time: 206 working days

idelalisib

Gilead Sciences Pty Ltd

For use, in combination with ofatumumab, for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) upon relapse in patients for whom chemo-immunotherapy is not considered suitable.

CIMZIA

Evaluation commenced: 30 June 2015

Registration decision: 7 November 2016

Entry onto ARTG: 9 February 2017

Approval time: 225 working days

certolizumab pegol (rbe)

UCB Australia Pty Ltd

For use in combination with methotrexate (MTX) for the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with MTX or other disease-modifying antirheumatic drugs (DMARDs).

January 2017

VYTORIN

Evaluation commenced: 31 July 2015

Registration decision: 17 January 2017

Entry onto ARTG: 20 January 2017

Approval time: 191 working days

ezetimibe/simvastatin

Merck Sharp & Dohme (Australia) Pty Limited

For use in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their maximum tolerated dose of simvastatin and 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.

EZETROL

Evaluation commenced: 31 July 2015

Registration decision: 17 January 2017

Entry onto ARTG: 20 January 2017

Approval time: 191 working days

ezetimibe

Merck Sharp & Dohme (Australia) Pty Limited

For administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit 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.

AFINITOR

Evaluation commenced: 24 December 2015

Registration decision: 13 January 2017

Entry onto ARTG: 20 January 2017

Approval time: 224 working days

everolimus

Novartis Pharmaceuticals Aust Pty Ltd

For the treatment of progressive, unresectable or metastatic, well-differentiated, non-functional neuroendocrine tumours (NET) of gastrointestinal or lung origin in adults.

JARDIANCE

Evaluation commenced: 29 February 2016

Registration decision: 6 January 2017

Entry onto ARTG: 18 January 2017

Approval time: 193 working days

empagliflozin

Boehringer Ingelheim Pty Ltd

To reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease.

AMOXICLAV JUNO and JUNOXICLAV

Evaluation commenced: 29 February 2016

Registration decision: 13 January 2017

Entry onto ARTG: 18 January 2017

Approval time: 175 working days

amoxicillin sodium and clavulanic acid

Juno Pharmaceuticals Pty Ltd

As an antibiotic alternative to narrow- and broad-spectrum antibiotics for the treatment of infections.

VasoKINOX

Evaluation commenced: 31 March 2015

Registration decision: 18 March 2016

Entry onto ARTG: 16 January 2017

Approval time: 197 working days

nitric oxide

Biotech Regulatory Solutions

In conjunction with ventilator support and other appropriate active substances to selectively decrease pulmonary arterial pressure in patients with perioperative pulmonary hypertension in conjunction with heart surgery.

ACZONE

Evaluation commenced: 23 December 2015

Registration decision: 4 January 2017

Entry onto ARTG: 10 January 2017

Approval time: 214 working days

dapsone

Allergan Australia Pty Ltd

For the topical treatment of acne vulgaris in patients 12 years of age and older.