Prescription medicines: registration of new chemical entities in Australia

7 June 2017

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

2017: May Apr Mar Feb Jan

Previous years: 2016 2015 2014

May 2017

New prescription medicines containing new active substances in May 2017
Medicine Date registered

PHEBURANE

sodium phenylbutyrate

Sponsor: Orpharma Pty Ltd

Pheburane is indicated for the management of hyperammonaemia associated with urea cycle disorders. Pheburane should be used with dietary protein restriction and, in some cases, dietary supplements (e.g. essential amino acids, arginine, citrulline, and protein-free calorie supplements).

30 May 2017

LONSURF/ORCANTAS

trifluridine/tipiracil hydrochloride

Sponsor: Servier Laboratories (Aust) Pty Ltd

Lonsurf/Orcantas is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.

23 May 2017

UROREC

silodosin

Sponsor: Mayne Pharma International Pty Ltd

Urorec is indicated for the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia in adult men.

23 May 2017

REXULTI

brexipiprazole

Sponsor: Lundbeck Australia Pty Limited

Rexulti is indicated in adult patients for the treatment of schizophrenia.

19 May 2017

REVESTIVE orphan drug

teduglutide

Sponsor: Shire Australia Pty Ltd

Revestive is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. Patients should be stable at least to 4 weeks on their parenteral support regimen before initiating teduglutide therapy.

19 May 2017

KANUMA orphan drug

sebelipase alfa rce

Sponsor: Alexion Pharmaceuticals Australasia Pty Ltd

Kanuma is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase deficiency (LAL-D).

18 May 2017

IBRANCE

palbociclib

Sponsor: Pfizer Australia Pty Ltd

Ibrance is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

  • an aromatase inhibitor as initial endocrine-based therapy
  • fulvestrant in patients who have received prior therapy.
3 May 2017

April 2017

New prescription medicines containing new active substances in April 2017
Medicine Date registered

AFSTYLA orphan drug

lonoctocog alfa (recombinant single-chain coagulation factor VIII)

Sponsor: CSL Behring Australia Pty Ltd

Afstyla is indicated in adult and paediatric patients with haemophilia A (congenital FVIII deficiency) for:

  • Control and prevention of bleeding episodes
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
  • Perioperative management (surgical prophylaxis).

Afstyla is not indicated for the treatment of von Willebrand disease.

13 Apr 2017

March 2017

New prescription medicines containing new active substances in March 2017
Medicine Date registered

REKOVELLE

follitropin delta (rhu)

Sponsor: Ferring Pharmaceuticals Pty Ltd

Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

31 Mar 2017

ADYNOVATE

rurioctocog alfa pegol (antihaemophilic factor VIII Recombinant Coagulation Factor VIII rch)

Sponsor: Baxalta Australia Pty Ltd

Adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia A (congenital factor VIII deficiency) patients for:

  • Control and prevention of bleeding episodes
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
  • Perioperative management (surgical prophylaxis).

It is not indicated for the treatment of von Willebrand disease.

21 Mar 2017

ALECENSA orphan drug

alectinib

Sponsor: Roche Products Pty Ltd

For the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

14 Mar 2017

GRAZAX

standardised allergen extract of grass pollen from Timothy grass (Phleum pratense)

Sponsor: Seqirus Pty Ltd

For disease modifying treatment of grass pollen (Phleum pratense or allergens cross reacting with P. pratense) induced allergic rhinitis with or without conjunctivitis in adults, adolescents and children above the age of 5 years.

7 Mar 2017

February 2017

New prescription medicines containing new active substances in February 2016
Medicine Date registered

ZEMAIRA orphan drug

human alpha-1-proteinase inhibitor

Sponsor: CSL Behring Australia Pty Ltd

For maintenance treatment to slow the progression of emphysema in adults with documented severe A1-PI deficiency and progressive lung disease.

13 Feb 2017

January 2017

New prescription medicines containing new active substances in January 2017
Medicine Date registered

VENCLEXTA

venetoclax

Sponsor: Abbvie Pty Ltd

For the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) with 17p deletion, or patients with relapsed or refractory CLL for whom there are no other suitable treatment options.

5 Jan 2017