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Prescription medicines: registration of new chemical entities in Australia

15 May 2019

Each year, TGA registers approximately 40 new prescription medicines containing new active substances. We refer to these as New Chemical Entities (NCEs) or New Biological Entities (NBEs).

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

This decision by TGA to register a NCE/NBE often comes after years of research and development and following a comprehensive review by TGA scientists and clinicians of the medicine's quality, safety and efficacy.

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

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

Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. TGA works to business target timeframes as well as to legislated timeframes for each category of application. Approval times are underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, the time allocated to the sponsor to respond to requests for information, 'mutual clock stop' periods agreed with the sponsor, or other review activities.

Approval times are reported in the number of TGA working days for each new registration, along with the legislated timeframe (unless otherwise indicated) for that category of application in brackets.


symbol denoting an orphan drug

Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market

symbol denoting a priority determination

Priority review: involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available


Registration of NCEs, 2019

Previous years

2018 2017 2016 2015 2014

April 2019

VERZENIO

Evaluation commenced: 2 Aug 2018

Registration decision: 8 Apr 2019

Date registered: 8 Apr 2019

Approval time: 141 working days (255)

abemaciclib

Eli Lilly Australia Pty Ltd

VERZENIO (tablets) is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or following prior endocrine therapy.

In pre- or peri-menopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

March 2019

NERLYNX

Evaluation commenced: 30 Apr 2018

Registration decision: 14 Mar 2019

Date registered: 15 Mar 2019

Approval time: 200 working days (255)

neratinib maleate

Specialised Therapeutics PM Pty Ltd

NERLYNX (film coated tablets) is indicated for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab based therapy.

ALUNBRIG orphan drug

Evaluation commenced: 4 Apr 2018

Registration decision: 4 Mar 2019

Date registered: 6 Mar 2019

Approval time: 190 working days (255)

brigatinib

Takeda Pharmaceuticals Australia Pty Ltd

ALUNBRIG (film-coated tablet) is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. The approval of this medicine is based on objective response rate and duration of response in a non-comparative study.

SYMDEKO orphan drug

Evaluation commenced: 31 Jan 2018

Registration decision: 1 Mar 2019

Date registered: 5 Mar 2019

Approval time: 228 working days (255)

ivacaftor; tezacaftor

Vertex Pharmaceuticals Australia Pty Ltd

Symdeko (film-coated tablets) is indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.

February 2019

STAQUIS

Evaluation commenced: 30 Nov 2017

Registration decision: 15 Feb 2019

Date registered: 20 Feb 2019

Approval time: 249 working days (255)

crisaborole

Pfizer Australia Pty Ltd

STAQUIS (2% w/w ointment) is indicated for topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.

PIFELTRO

Evaluation commenced: 31 Jan 2018

Registration decision: 18 Jan 2019

Date registered: 4 Feb 2019

Approval time: 198 working days (255)

doravirine

Merck Sharp & Dohme (Australia) Pty Ltd

PIFELTRO is indicated, in combination with other antiretroviral medicinal products, for the treatment of HIV-1 infection in adults who are antiretroviral therapy (ART) naÏve with no known substitutions associated with resistance to doravirine.

January 2019

TAKHZYRO orphan drugpriority review

Evaluation commenced: 25 May 2018

Registration decision: 24 Jan 2019

Date registered: 30 Jan 2019

Approval time: 147 working days (255)

lanadelumab

Shire Australia Pty Ltd

TAKHZYRO is indicated for routine prevention of recurrent attacks of hereditary angioedema (C1-esterase-inhibitor deficiency or dysfunction) in patients aged 12 years and older.

XIIDRA

Evaluation commenced: 31 Oct 2017

Registration decision: 18 Jan 2019

Date registered: 21 Jan 2019

Approval time: 216 working days (255)

lifitegrast

Shire Australia Pty Ltd

XIIDRA (eye drops) is indicated for the treatment of moderate to severe dry eye disease in adults for whom prior use of artificial tears has not been sufficient.

MEKTOVI

Evaluation commenced: 30 Nov 2017

Registration decision: 30 Nov 2018

Date registered: 3 Jan 2019

Approval time: 198 working days (255)

binimetinib

Pierre Fabre Australia Pty Ltd

MEKTOVI in combination with BRAFTOVI (encorafenib) is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by a validated test.

BRAFTOVI

Evaluation commenced: 30 Nov 2017

Registration decision: 30 Nov 2018

Date registered: 3 Jan 2019

Approval time: 198 working days (255)

encorafenib

Pierre Fabre Australia Pty Ltd

BRAFTOVI in combination with MEKTOVI (binimetinib) is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by a validated test.