Prescription medicines: registration of new chemical entities in Australia

9 August 2018

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, 2018

Previous years

2017 2016 2015 2014

July 2018

BIKTARVY

Evaluation commenced: 31 Aug 2017

Registration decision: 10 Jul 2018

Date registered: 12 Jul 2018

Approval time: 195 working days (255)

Bictegravir sodium; tenofovir alafenamide fumarate; emtricitabine

Gilead Sciences Pty Ltd

BIKTARVY (tablets) is indicated for the treatment of HIV-1 infection in adults who are antiretroviral therapy (ART)-naïve or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA < 50 copies per mL) on a stable antiretroviral regimen at the start of therapy with no history of treatment failure, and no known substitutions associated with resistance to the individual components of BIKTARVY.

ERLYAND, JANSSEN APALUTAMIDE priority review

Evaluation commenced: 7 Mar 2018

Registration decision: 4 Jul 2018

Date registered: 5 Jul 2018

Approval time: 110 working days (255)

Apalutamide

Janssen-Cilag Pty Ltd

ERLYAND, JANSSEN APALUTAMIDE (tablets) is indicated for the treatment of patients with non-metastatic, castration-resistant prostate cancer.

AIMOVIG

Evaluation commenced: 31 Jul 2017

Registration decision: 28 Jun 2018

Date registered: 2 Jul 2018

Approval time: 178 working days (255)

Erenumab

Novartis Pharmaceuticals Australia Pty Ltd

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

SHINGRIX

Evaluation commenced: 28 Jun 2017

Registration decision: 27 Jun 2018

Date registered: 2 Jul 2018

Approval time: 207 working days (255)

Recombinant Varicella Zoster Virus glycoprotein E antigen

GlaxoSmithKline Australia Pty Ltd

SHINGRIX (powder and suspension for suspension for injection) is indicated for the prevention of herpes zoster and post-herpetic neuralgia in adults 50 years of age or older

June 2018

INOVELON orphan drug

Evaluation commenced: 24 Apr 2017

Registration decision: 22 Jun 2018

Date registered: 27 Jun 2018

Approval time: 240 working days (255)

Rufinamide

Eisai Australia Pty Ltd

INOVELON (tablets) is indicated as adjunctive therapy in the treatment of seizures associated with Lennox Gastaut syndrome in patients 4 years of age and older.

PREVYMIS orphan drug

Evaluation commenced: 31 Jul 2017

Registration decision: 21 Jun 2018

Date registered: 22 Jun 2018

Approval time: 180 working days (255)

Letermovir

Merck Sharp & Dohme (Australia) Pty Ltd

PREVYMIS (tablets; injections) is indicated for the prophylaxis of cytomegalovirus (CMV) infection or disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

May 2018

RYDAPT orphan drug

Evaluation commenced: 1 May 2017

Registration decision: 7 May 2018

Date registered: 17 May 2018

Approval time: 213 working days (255)

Midostaurin

Novartis Pharmaceuticals Australia Pty Ltd

RYDAPT capsules are indicated for:

  • in combination with standard anthracycline and cytarabine induction and cytarabine consolidation chemotherapy, followed in patients in complete response by single agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive
  • the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasms (SMAHB) or mast cell leukaemia (MCL)

BESPONSA orphan drug

Evaluation commenced: 1 Jun 2017

Registration decision: 11 May 2018

Date registered: 17 May 2018

Approval time: 195 working days (255)

Inotuzumab ozogamicin

Pfizer Pty Ltd

BESPONSA powder of injection is indicated for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL).

STEGLATRO

Evaluation commenced: 31 May 2017

Registration decision: 14 May 2018

Date registered: 17 May 2018

Approval time: 235 working days (255)

Ertugliflozin

Merck Sharp & Dohme (Australia) Pty Ltd

STEGLATRO tablets are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:

  • monotherapy when metformin is considered inappropriate due to intolerance; or
  • in combination with other anti-hyperglycaemic agents.

April 2018

FASENRA

Evaluation commenced: 31 Mar 2017

Registration decision: 29 Mar 2018

Date registered: 2 Apr 2018

Approval time: 215 working days (255)

benralizumab

AstraZeneca Pty Ltd

Fasenra injection is indicated as add-on therapy in patients aged 12 years and over with severe eosinophilic asthma (blood eosinophil count ≥300 cells/µL or ≥150 cells/µL if on oral corticosteroid treatment).

March 2018

RAPIVAB

Evaluation commenced: 28 Feb 2017

Registration decision: 16 Mar 2018

Date registered: 21 Mar 2018

Approval time: 218 working days (255)

peramivir

Seqirus Pty Ltd

Rapivab intravenous infusion is indicated for the treatment of acute influenza infection in adults and children 2 years and older who have been symptomatic for no more than two days.

VOSEVI

Evaluation commenced: 31 Mar 2017

Registration decision: 13 Mar 2018

Date registered: 16 Mar 2018

Approval time: 222 working days (255)

sofosbuvir/velpatasvir/voxilaprevir

Gilead Sciences Pty Ltd

VOSEVI tablets are indicated for the treatment of chronic hepatitis C virus (HCV) infection in adult patients, without cirrhosis or with compensated cirrhosis, who have:

  • genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor
  • genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor.

JANSSEN GUSELKUMAB, TREMFYA

Evaluation commenced: 31 Mar 2017

Registration decision: 8 Mar 2018

Date registered: 15 Mar 2018

Approval time: 194 working days (255)

guselkumab

Janssen-Cilag Pty Ltd

Janssen Guselkumab and Tremfya solution for injection is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

February 2018

HEMLIBRA orphan drugpriority review

Evaluation commenced: 22 Sep 2017

Registration decision: 22 Feb 2018

Date registered: 23 Feb 2018

Approval time: 104 working days (255)

emicizumab (rch)

Roche Products Pty Limited

Hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in adult and paediatric patients with haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

January 2018

DUPIXENT

Evaluation commenced: 3 Jan 2017

Registration decision: 22 Jan 2018

Date registered: 24 Jan 2018

Approval time: 242 working days (255)

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

Approval time: 163 working days (255)

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

Approval time: 198 working days (255)

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

Approval time: 218 working days (255)

Aelumab (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

Approval time: 181 working days (255)

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.