You are here

Prescription medicines: registration of new chemical entities in Australia

2 September 2020

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, 2020

Previous years

2019 2018 2017 2016 2015 2014

August 2020

TUKYSA priority review

Evaluation commenced: 2 Mar 2020

Registration decision: 13 Aug 2020

Date registered: 13 Aug 2020

Approval time: 113 working days (255)

tucatinib

AA-Med Pty Ltd

TUKYSA (film coated tablet) is indicated in combination with trastuzumab and capecitabine for treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.

LUXTURNA orphan drug

Evaluation commenced: 31 Jul 2019

Registration decision: 4 Aug 2020

Date registered: 5 Aug 2020

Approval time: 208 working days (255)

voretigene neparvovec

Novartis Pharmaceuticals Australia Pty Ltd

LUXTURNA (concentrated solution for injection) is indicated for the treatment of patients with inherited retinal dystrophy caused by pathological biallelic RPE65 mutations and who have sufficient viable retinal cells as determined by the treating physician.

Pathological mutations of RPE65 should be confirmed by a National Association of Testing Authorities (NATA) or International Laboratory Accreditation Cooperation (ILAC) accredited laboratory.

July 2020

FLUZONE HIGH-DOSE QIV

Evaluation commenced: 2 Sep 2019

Registration decision: 30 Jul 2020

Date registered: 31 Jul 2020

Approval time: 204 working days (255)

influenza virus haemagglutinin

Sanofi-Aventis Australia Pty Ltd

FLUZONE HIGH-DOSE QIV (suspension for injection) is indicated for active immunisation for the prevention of influenza disease. Fluzone High-Dose Quadrivalent is indicated for use in persons 65 years of age and older.

The use of Fluzone High-Dose Quadrivalent (QIV) should be based on official recommendations.

See Section 5.1 Clinical Trials for information on the effects on influenza associated complications.

DEFITELIO orphan drug

Evaluation commenced: 31 Jul 2019

Registration decision: 15 Jul 2020

Date registered: 23 Jul 2020

Approval time: 223 working days (255)

defibrotide

Link Medical Products Pty Ltd T/A Link Pharmaceuticals

DEFITELIO (concentrated solution for injection) is indicated for the treatment of severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy.

It is indicated in adults and in adolescents, children and infants of 1 month of age and above.

LIBTAYO provisional registration

Evaluation commenced: 30 Aug 2019

Registration decision: 16 Jul 2020

Date registered: 17 Jul 2020

Approval time: 195 working days (255)

cemiplimab

Sanofi-Aventis Australia Pty Ltd

LIBTAYO (concentrate for solution for infusion) as monotherapy has provisional approval in Australia for the treatment of adult patients with metastatic or locally advanced cutaneous squamous cell carcinoma (mCSCC or laCSCC) who are not candidates for curative surgery or curative radiation.

The decision to approve this indication has been made on the basis of objective response rate (ORR) and duration of response from single arm clinical studies. The sponsor is required to submit further clinical data to confirm the clinical benefit of the medicine.

ZEPOSIA

Evaluation commenced: 31 Jul 2019

Registration decision: 16 Jul 2020

Date registered: 17 Jul 2020

Approval time: 218 working days (255)

ozanimod hydrochloride

Celgene Pty Ltd

ZEPOSIA (capsule) is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis.

QINLOCK orphan drugpriority review

Evaluation commenced: 13 Jan 2020

Registration decision: 10 Jul 2020

Date registered: 13 Jul 2020

Approval time: 123 working days (255)

ripretinib

Tudorrose Consulting Pty Ltd

QINLOCK (tablet) is a kinase inhibitor indicated for the treatment of adult patients with advanced gastrointestinal stromal tumours (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

VEKLURY provisional registration

Evaluation commenced: 6 Jul 2020

Registration decision: 10 Jul 2020

Date registered: 10 Jul 2020

Approval time: 5 working days (255)

remdesivir

Gilead Sciences Pty Ltd

VEKLURY has provisional approval for the treatment of Coronavirus Disease 2019 (COVID-19) in adults and adolescents (aged 12 years and older weighing at least 40 kg) with pneumonia, requiring supplemental oxygen.

The decision to approve this medicine has been made based on limited data. More comprehensive evidence is required to be submitted.

May 2020

ROZLYTREK provisional registration

Evaluation commenced: 1 Jul 2019

Registration decision: 18 May 2020

Date registered: 19 May 2020

Approval time: 202 working days (255)

entrectinib

Roche Products Pty Ltd

Non-small cell lung cancer (NSCLC)

ROZLYTREK (hard capsule) is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours are ROS1-positive.

Solid tumours

ROZLYTREK is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that:

  • have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation,
  • are metastatic or where surgical resection is likely to result in severe morbidity, and
  • have either progressed following treatment or have no satisfactory alternative therapy.

This indication was approved via the provisional approval pathway, based on objective response rate and duration of response in single-arm trials. Full registration for this indication depends on verification and description of clinical benefit in confirmatory trials.

SARCLISA orphan drug

Evaluation commenced: 30 Jul 2019

Registration decision: 5 May 2020

Date registered: 6 May 2020

Approval time: 166 working days (255)

isatuximab

Sanofi-Aventis Australia Pty Ltd

SARCLISA (concentrated solution for injection) is indicated in combination with pomalidomide and dexamethasone, for the treatment of patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI).

April 2020

VEYVONDI IU

Evaluation commenced: 3 Jun 2019

Registration decision: 15 Apr 2020

Date registered: 20 Apr 2020

Approval time: 173 working days (175)

vonicog alfa

Shire Australia Pty Ltd

VEYVONDI (powder for injection with solvent vials) is indicated in adults (age 18 and older) with von Willebrand Disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or not indicated, for the:

  • treatment of haemorrhage and surgical bleeding
  • prevention of surgical bleeding.

VEYVONDI should not be used in the treatment of Haemophilia A.

MYLOTARG

Evaluation commenced: 13 Jun 2019

Registration decision: 8 Apr 2020

Date registered: 9 Apr 2020

Approval time: 175 working days (255)

gemtuzumab ozogamicin

Pfizer Australia Pty Ltd

MYLOTARG (powder for injection) is indicated for combination therapy with standard anthracycline and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL) (see Section 4.4 Special warnings and precautions for use, and Section 5.1 Pharmacodynamic properties).

QARZIBA orphan drugpriority review

Evaluation commenced: 28 Aug 2019

Registration decision: 18 Mar 2020

Date registered: 2 Apr 2020

Approval time: 137 working days (255)

dinutuximab beta

Emerge Health Pty Ltd

QARZIBA (concentrated solution for injection) is indicated for the treatment of high-risk neuroblastoma in patients who have previously received induction chemotherapy and achieved at least a partial response.

XOSPATA orphan drugpriority review

Evaluation commenced: 23 Aug 2019

Registration decision: 2 Apr 2020

Date registered: 2 Apr 2020

Approval time: 151 working days (255)

gilteritinib fumarate

Astellas Pharma Australia Pty Ltd

XOSPATA (film coated tablets) is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.

March 2020

PIQRAY

Evaluation commenced: 1 Apr 2019

Registration decision: 19 Mar 2020

Date registered: 20 Mar 2020

Approval time: 195 working days (255)

alpelisib

Novartis Pharmaceuticals Australia Pty Ltd

PIQRAY (film coated tablet) in combination with fulvestrant, is indicated for the treatment of postmenopausal women, and men, with hormone receptor positive, HER2-negative, advanced or metastatic breast cancer with a PIK3CA mutation as detected by a validated test following progression on or after an endocrine-based regimen.

VYNDAMAX orphan drug

Evaluation commenced: 11 Apr 2019

Registration decision: 13 Mar 2020

Date registered: 16 Mar 2020

Approval time: 187 working days (255)

tafamidis

Pfizer Australia Pty Ltd

VYNDAMAX (soft capsules) is indicated for the treatment of adult patients with wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM).

VYNDAQEL orphan drug

Evaluation commenced: 11 Apr 2019

Registration decision: 13 Mar 2020

Date registered: 16 Mar 2020

Approval time: 187 working days (255)

tafamidis meglumine

Pfizer Australia Pty Ltd

VYNDAQEL (soft capsules) is indicated for the treatment of adult patients with wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM).

February 2020

NUBEQA

Evaluation commenced: 30 May 2019

Registration decision: 20 Feb 2020

Date registered: 26 Feb 2020

Approval time: 182 working days (255)

darolutamide

Bayer Australia Ltd

NUBEQA (tablets) is indicated for the treatment of patients with non-metastatic castration resistant prostate cancer (nmCRPC).

XOFLUZA

Evaluation commenced: 31 May 2019

Registration decision: 21 Feb 2020

Date registered: 21 Feb 2020

Approval time: 161 working days (255)

baloxavir marboxil

Roche Products Pty Ltd

XOFLUZA (film-coated tablet) is indicated for the treatment of uncomplicated influenza in patients aged 12 years of age and older who have been symptomatic for no more than 48 hours and who are:

  • otherwise healthy, or
  • at high risk of developing influenza complications.

ENOXAPO

Evaluation commenced: 22 Jul 2013

Registration decision: 4 Feb 2020

Date registered: 10 Feb 2020

Approval time: 142 working days (255)

enoxaparin sodium

Apotex Pty Ltd

ENOXAPO (solution for injection) is indicated for the prevention of thromboembolic disorders of venous origin in patients undergoing orthopaedic and general surgery.

ENOXAPO is indicated for the prophylaxis of venous thromboembolism in medical patients bedridden due to acute illness.

ENOXAPO is indicated for the prevention of thrombosis in extra-corporeal circulation during haemodialysis.

ENOXAPO is indicated for the treatment of established deep vein thrombosis.

ENOXAPO is indicated for the treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin.

ENOXAPO is indicated for the treatment of acute ST-segment Elevation Myocardial Infarction (STEMI) as an adjunctive to thrombolytic treatment, including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).

CABLIVI orphan drug

Evaluation commenced: 1 Jul 2019

Registration decision: 31 Jan 2020

Date registered: 5 Feb 2020

Approval time: 104 working days (120)

caplacizumab

Sanofi-Aventis Australia Pty Ltd

CABLIVI (powder for injection) is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.

January 2020

IDHIFA orphan drugprovisional registration

Evaluation commenced: 2 Jan 2019

Registration decision: 16 Jan 2020

Date registered: 17 Jan 2020

Approval time: 220 working days (255)

enasidenib

Celgene Pty Ltd

IDHIFA (film-coated tablet) has Provisional Approval in Australia for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia who are ineligible for haematopoietic stem cell transplant, and who have an isocitrate dehydrogenase-2 (IDH2) mutation confirmed by a validated diagnostic test.

The decision to approve this indication has been made on the basis of preliminary clinical data from a Phase 1/2 clinical trial with a primary endpoint of overall response rate. An improvement in OS or PFS has not been established. The sponsor is required to submit further clinical data to confirm the efficacy and safety of the medicine.

RINVOQ

Evaluation commenced: 31 Jan 2019

Registration decision: 17 Jan 2020

Date registered: 17 Jan 2020

Approval time: 222 working days (255)

upadacitinib hemihydrate

Abbvie Pty Ltd

RINVOQ (modified release tablet) is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs).

RINVOQ may be used as monotherapy or in combination with methotrexate or other conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs).

BEOVU

Evaluation commenced: 6 Mar 2019

Registration decision: 15 Jan 2020

Date registered: 16 Jan 2020

Approval time: 189 working days (255)

brolucizumab

Novartis Pharmaceuticals Australia Pty Ltd

BEOVU (solution for injection) is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).