Prescription medicines: registration of new chemical entities in Australia

1 February 2018

Each year, approximately 40 new prescription medicines containing new active substances are registered. These are called New Chemical Entities (NCEs) by the TGA.

Some of these NCEs are innovative or 'first-in-class', and have been made available for the first time outside the controlled environment of a clinical trial.

This decision by the TGA often comes after years of research and development and following a comprehensive review by the TGA scientists and clinicians of the quality, safety and efficacy of the new prescription medicines.

Throughout the year we will be publishing information on the new prescription medicines when they are approved. However, it may still be some time before the pharmaceutical company decides to supply the product in Australia.

The trade name, sponsor and active ingredient for each medicine reflects the information initially entered in the Australian Register of Therapeutic Goods (ARTG).

Registration of NCEs

Orphan drug orphan drug

2018: Jan

Previous years: 2017 2016 2015 2014

January 2018

DUPIXENT

Evaluation commenced: 3 Jan 2017

Registration decision: 22 Jan 2018

Date registered: 24 Jan 2018

dupilumab (rch)

Sanofi-Aventis Australia Pty Ltd

Dupixent is indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for chronic systemic therapy. Dupixent is not intended for episodic use.

OLUMIANT

Evaluation commenced: 1 Aug 2016

Registration decision: 19 Jan 2018

Date registered: 23 Jan 2018

baricitinib

Eli Lilly Australia Pty Ltd

Olumiant is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately, or who are intolerant, to one or more disease-modifying anti-rheumatic drugs (DMARDs). Olumiant can be taken as monotherapy or in combination with conventional DMARDs, including methotrexate (MTX).

CABOMETYX

Evaluation commenced: 31 Jan 2017

Registration decision: 18 Jan 2018

Date registered: 19 Jan 2018

cabozantinib (as (S)-malate)

Ipsen Pty Ltd

Cabometyx is indicated for the treatment of advanced renal cell carcinoma (RCC) in adults following prior treatment with vascular endothelial growth factor targeted therapy.

BAVENCIO orphan drug

Evaluation commenced: 3 Jan 2017

Registration decision: 2 Jan 2018

Date registered: 3 Jan 2018

avelumab (rch)

Merck Serono Australia Pty Ltd

Bavencio is indicated for the treatment of adults and paediatric patients 12 years and older with metastatic Merkel Cell Carcinoma (mMCC).

MAVIRET

Evaluation commenced: 28 Feb 2017

Registration decision: 21 Dec 2017

Date registered: 2 Jan 2018

glecaprevir / pibrentasvir

AbbVie Pty Ltd

Maviret is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection with or without compensated cirrhosis. This includes patients with HCV genotype 1 infection who were previously treated with either a regimen of an NS5A inhibitor or with an NS3/4A protease inhibitor but not both classes of inhibitors.