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

14 July 2017

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.

Registration of new or extended uses of registered medicines

Orphan drug orphan drug

2017: Jul Jun May Apr Mar Feb Jan

Previous years: 2016

July 2017

'Extension of Indications' registrations, July 2017
Medicine Date registered

OPDIVO

nivolumab

Sponsor: 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.

11 July 2017

TRAJENTAMET

linagliptin / metformin hydrochloride

Sponsor: 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.

6 July 2017

TRAJENTA

linagliptin

Sponsor: 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.

6 July 2017

MENVEO

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

Sponsor: 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.

5 July 2017

June 2017

'Extension of Indications' registrations, June 2017
Medicine Date registered

OZURDEX

dexamethasone

Sponsor: 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.

16 June 2017

XELJANZ

tofacitinib (as citrate)

Sponsor: 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.

6 June 2017

CEREZYME orphan drug

imiglucerase-rch

Sponsor: 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.

6 June 2017

May 2017

'Extension of Indications' registrations, May 2017
Medicine Date registered

OPDIVO

nivolumab

Sponsor: 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.

30 May 2017

ATOZET/ZETEZEs

ezetimibe and atorvastatin

Sponsor: 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.

24 May 2017

April 2017

'Extension of Indications' registrations, April 2017
Medicine Date registered

JARDIAMET

empagliflozin / metformin hydrochloride

Sponsor: 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.

28 Apr 2017

VIEKIRA PAK-RBV

paritaprevir/ritonavir/ombitasvir & dasabuvir & ribavirin

Sponsor: 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.

21 Apr 2017

VIEKIRA PAK

paritaprevir/ritonavir/ombitasvir & dasabuvir

Sponsor: 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.

21 Apr 2017

March 2017

'Extension of Indications' registrations, March 2017
Medicine Date registered

JINARC

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.

24 Mar 2017

KEYTRUDA

pembrolizumab (rch)

Sponsor: 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.

21 Mar 2017

PEDEA orphan drug

ibuprofen

Sponsor: Emerge Health Pty Ltd

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

14 Mar 2017

EPIDUO FORTE

adapalene / benzoyl peroxide

Sponsor: 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.

10 Mar 2017

KEYTRUDA

pembrolizumab

Sponsor: 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.

6 Mar 2017

KEYTRUDA

pembrolizumab

Sponsor: 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.

7 Mar 2017

STELARA

ustekinumab

Sponsor: 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.

1 Mar 2017

February 2017

'Extension of Indications' registrations, February 2017
Medicine Date registered

ZYDELIG

idelalisib

Sponsor: 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.

10 Feb 2017

CIMZIA

certolizumab pegol (rbe)

Sponsor: 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).

9 Feb 2017

January 2017

'Extension of Indications' registrations, January 2017
Medicine Date registered

VEMLIDY

tenofovir alafenamide (as fumarate)

Sponsor: Gilead Sciences Pty Ltd

For the treatment of chronic hepatitis B in adults.

22 Jan 2017

VYTORIN

ezetimibe/simvastatin

Sponsor: 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.

20 Jan 2017

EZETROL

ezetimibe

Sponsor: 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.

20 Jan 2017

AFINITOR

everolimus

Sponsor: 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.

20 Jan 2017

JARDIANCE

empagliflozin

Sponsor: Boehringer Ingelheim Pty Ltd

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

18 Jan 2017

AMOXICLAV JUNO and JUNOXICLAV

amoxicillin sodium and clavulanic acid

Sponsor: Juno Pharmaceuticals Pty Ltd

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

18 Jan 2017

VasoKINOX

nitric oxide

Sponsor: 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.

16 Jan 2017

ACZONE

dapsone

Sponsor: Allergan Australia Pty Ltd

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

10 Jan 2017