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

12 April 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 inebsite.

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.formation relating to new or extended uses of registered prescription medicines on the TGA w

Registration of new or extended uses of registered medicines

Orphan drug orphan drug

2017: Mar Feb Jan

Previous years: 2016

March 2017

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

JINARC

tolvaptan

Sponsor: Commercial Eyes 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 March 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 March 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 March 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 March 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 March 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 March 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 March 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 February 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 February 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 January 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 January 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 January 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 January 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 January 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 January 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 January 2017

ACZONE

dapsone

Sponsor: Allergan Australia Pty Ltd

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

10 January 2017