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Prescription medicines: registration of new chemical entities in Australia

5 November 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

symbol denoting a provisional registration

Provisional registration: involves early access to vital and life-saving medicines through time-limited registration


Registration of NCEs, 2019

Previous years

2018 2017 2016 2015 2014

October 2019

POLIVY priority review

Evaluation commenced: 15 Apr 2019

Registration decision: 21 Oct 2019

Date registered: 21 Oct 2019

Approval time: 130 working days (255)

polatuzumab vedotin

Roche Products Pty Ltd

POLIVY (powder for injection) in combination with bendamustine and rituximab is indicated for the treatment of previously treated adult patients with diffuse large B-cell lymphoma who are not candidates for hematopoietic stem cell transplant.

ULTOMIRIS orphan drug

Evaluation commenced: 2 Jan 2019

Registration decision: 8 Oct 2019

Date registered: 17 Oct 2019

Approval time: 173 working days (255)

ravulizumab

Alexion Pharmaceuticals Australasia Pty Ltd

ULTOMIRIS (concentrated solution for intravenous infusion) is indicated for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH).

OXERVATE orphan drugpriority review

Evaluation commenced: 24 Dec 2018

Registration decision: 16 Sep 2019

Date registered: 1 Oct 2019

Approval time: 181 working days (255)

cenegermin (rbe)

JACE Pharma Pty Ltd

OXERVATE (eye drops) is indicated for the treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.

FLUAD QUAD priority review

Evaluation commenced: 1 Mar 2019

Registration decision: 24 Sep 2019

Date registered: 1 Oct 2019

Approval time: 120 working days (255)

inactivated quadrivalent influenza vaccine

Seqirus Pty Ltd

FLUAD QUAD (adjuvanted suspension for injection) is indicated for the active immunisation against influenza in persons 65 years of age and older.

September 2019

AJOVY

Evaluation commenced: 28 Sep 2018

Registration decision: 17 Sep 2019

Date registered: 20 Sep 2019

Approval time: 202 working days (255)

fremanezumab

Teva Pharma Australia Pty Ltd

AJOVY (solution for injection) is indicated for the preventive treatment of migraine in adults.

UVADEX orphan drug

Evaluation commenced: 28 Sep 2018

Registration decision: 13 Sep 2019

Date registered: 16 Sep 2019

Approval time: 198 working days (255)

methoxsalen

Terumo BCT Australia Pty Ltd

UVADEX (concentrated solution for injection) is indicated for extracorporeal administration with the THERAKOS CELLEX Photopheresis System for the treatment of steroid-refractory and steroid-intolerant chronic graft versus host disease (cGvHD) in adults following allogeneic HSC transplantation.

DIACOMIT orphan drug

Evaluation commenced: 31 Oct 2016

Registration decision: 11 Sep 2019

Date registered: 13 Sep 2019

Approval time: 242 working days (255)

stiripentol

Emerge Health Pty Ltd

DIACOMIT (capsule/powder for oral suspension) is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (SMEI, also known as Dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.

REFIXIA

Evaluation commenced: 28 Sep 2018

Registration decision: 2 Sep 2019

Date registered: 4 Sep 2019

Approval time: 192 working days (255)

nonacog beta pegol

Novo Nordisk Pharmaceuticals Pty Ltd

REFIXIA (solution for injection) is indicated for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia B (congenital factor IX deficiency).

August 2019

OZEMPIC

Evaluation commenced: 3 Oct 2018

Registration decision: 15 Aug 2019

Date registered: 28 Aug 2019

Approval time: 177 working days (255)

semaglutide (rys)

Novo Nordisk Pharmaceuticals Pty Ltd

OZEMPIC (solution for injection) is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:

  • as monotherapy when metformin is not tolerated or contraindicated.
  • in addition to other medicinal products for the treatment of type 2 diabetes.

July 2019

SKYRIZI

Evaluation commenced: 2 Jul 2018

Registration decision: 15 Jul 2019

Date registered: 16 Jul 2019

Approval time: 217 working days (255)

risankizumab

Abbvie Pty Ltd

SKYRIZI (solution for injection) is indicated for the treatment of moderate to severe plaque psoriasis in adults (18 years or older) who are candidates for phototherapy or systemic therapy.

EVENITY

Evaluation commenced: 5 Jan 2018

Registration decision: 21 Jun 2019

Date registered: 1 Jul 2019

Approval time: 239 working days (255)

romosozumab

Amgen Australia Pty Ltd

EVENITY (solution for injection) is indicated for:

  • The treatment of osteoporosis in postmenopausal women at high risk of fracture (see Section 5.1 Pharmacodynamic properties, Clinical trials).
  • Treatment to increase bone mass in men with osteoporosis at high risk of fracture.

June 2019

ZEJULA

Evaluation commenced: 30 Aug 2018

Registration decision: 28 Jun 2019

Date registered: 28 Jun 2019

Approval time: 180 working days (255)

niraparib (as tosilate monohydrate)

Takeda Pharmaceuticals Australia Pty Ltd

ZEJULA (capsules) is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

CONSTELLA

Evaluation commenced: 31 Jan 2018

Registration decision: 28 May 2019

Date registered: 18 Jun 2019

Approval time: 245 working days (255)

linaclotide

Allergan Australia Pty Ltd

CONSTELLA (hard capsules) is indicated in adults for the treatment of:

  • irritable bowel syndrome with constipation (IBS-C) and
  • chronic idiopathic constipation (CIC) when dietary fibre, laxatives and stool softeners have not been sufficient and with adequate constipation minimisation dietary support.

May 2019

EMGALITY

Evaluation commenced: 31 May 2018

Registration decision: 22 May 2019

Date registered: 28 May 2019

Approval time: 208 working days (255)

galcenezumab

Eli Lilly Australia Pty Ltd

EMGALITY (solution for injection) is indicated for the prophylaxis of migraine in adults.

VAXIGRIP TETRA

Evaluation commenced: 29 Mar 2018

Registration decision: 15 May 2019

Date registered: 20 May 2019

Approval time: 168 working days (255)

Inactivated Quadrivalent Influenza Vaccine (Split Virion) influenza virus haemagglutinin

Sanofi-Aventis Australia Pty Ltd

VAXIGRIP TETRA (suspension for injection) is indicated for active immunisation of adults and children from 6 months of age and older for the prevention of influenza disease caused by the two influenza A virus subtypes and the two influenza B virus types contained in the vaccine.

CRESEMBA orphan drug

Evaluation commenced: 29 Jun 2018

Registration decision: 15 May 2019

Date registered: 17 May 2019

Approval time: 172 working days (175)

isavuconasole

Pfizer Australia Pty Ltd

CRESEMBA (capsules) is indicated in adults for the treatment of:

  • invasive aspergillosis
  • mucormycosis in patients for whom amphotericin B is inappropriate (see Section 4.4 Special warnings and precautions for use and Section 5.1 Pharmacodynamic properties)

Consideration should be given to official guidance on the appropriate use of antifungal agents.

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.

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.

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.