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

19 January 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.

Registration of new or extended uses of registered medicines

Orphan drug orphan drug

2018: Jan

Previous years: 2017 2016 2015 2014

January 2018

New prescription medicines containing new active substances in January 2018
Medicine Date registered

ORENCIA

abatacept (rch)

Sponsor: Bristol-Myers Squibb Australia Pty Ltd

Orencia is now also indicated for the treatment of active psoriatic arthritis (PsA) in adults when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Orencia can be used with or without non-biologic DMARDs.

Evaluation commenced: 10 January 2017
Registration decision: 10 January 2018

12 Jan 2018

KEYTRUDA

pembrolizumab (rch)

Sponsor: Merck Sharp & Dohme (Australia) Pty Ltd

Keytruda is now also indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

  • are not eligible for cisplatin-containing therapy. 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; or
  • have received platinum-containing chemotherapy

Evaluation commenced: 28 February 2017
Registration decision: 9 January 2018

11 Jan 2018

SAXENDA

liraglutide (rys)

Sponsor: Novo Nordisk Pharmaceuticals Pty Ltd

Saxenda is now also indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

  • ≥ 30 kg/m2 (obese); or
  • ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.

Evaluation commenced: 1 February 2017
Registration decision: 5 January 2018

8 Jan 2018

VICTOZA

liraglutide (rys)

Sponsor: Novo Nordisk Pharmaceuticals Pty Ltd

Victoza is now also indicated for:

  • Glycaemic control: Victoza is indicated as an adjunct to diet and exercise for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control as monotherapy when metformin is contraindicated or is not tolerated.
  • Prevention of cardiovascular events: In patients where Victoza is indicated to improve glycaemic control, Victoza is indicated to reduce the risk of cardiovascular events in those at high cardiovascular risk, as an adjunct to standard of care therapy.

Evaluation commenced: 1 February 2017
Registration decision: 5 January 2018

8 Jan 2018

AFINITOR orphan drug

everolimus

Sponsor: Novartis Pharmaceuticals Australia Pty Ltd

Afinitor is now also indicated for the adjunctive treatment of patients aged 2 years and older with Tuberous Sclerosis Complex (TSC) and associated refractory seizures.

Evaluation commenced: 31 January 2017
Registration decision: 22 December 2017

3 Jan 2018