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Prescription medicines: new or extended uses, or new combinations of registered medicines

23 June 2021

Over time, the approved therapeutic uses of prescription medicines registered on the Australian Register of Therapeutic Goods (ARTG) can change.

Changes commonly include 'new uses' or 'extended uses'. A new use is where an already registered medicine is approved for an additional therapeutic use. An extended use is where an already registered medicine is approved to treat a broader range of patients, e.g. a wider age range. New or extended uses are called 'extensions of indications'. By contrast, a 'new combination' is where two or more already registered medicines are combined into a single product.

The decision to approve an 'extension of indications' or 'new combination' for already registered prescription medicines follows a comprehensive review by TGA scientists and clinicians on the quality, safety and efficacy of the proposed use of the medicine.

Throughout the year, we will be publishing information relating to new or extended uses, or new combinations of registered prescription medicines on the TGA website.

The trade name, active ingredient, and sponsor for each medicine reflects the information entered into the ARTG when the new or extended use was first approved. This webpage provides a summary of the newly added indications; for a full list of each medicine's registered indications, please refer to the Product Information database.

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 new or extended uses of registered medicines, 2021

Previous years

2020 2019 2018 2017 2016

May 2021

FERINJECT

Evaluation commenced: 11 May 2020

Registration decision: 13 May 2021

Date registered: 28 May 2021

Approval time: 189 (255 working days)

ferric carboxymaltose

Vifor Pharma Pty Ltd

FERINJECT (solution for injection) is now also indicated for the treatment of iron deficiency when there is a clinical need to deliver iron rapidly.

XOFLUZA

Evaluation commenced: 2 Jun 2020

Registration decision: 19 May 2021

Date registered: 27 May 2021

Approval time: 226 (255 working days)

baloxavir marboxil

Roche Products Pty Ltd

Prophylaxis of influenza

XOFLUZA (tablet) is now also indicated for the post-exposure prophylaxis of influenza in patients aged 12 years of age and older following contact with an individual who has confirmed influenza.

Vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

ZAVICEFTA

Evaluation commenced: 2 Jun 2020

Registration decision: 13 May 2021

Date registered: 18 May 2021

Approval time: 195 (255 working days)

avibactam sodium; ceftazidime pentahydrate

Pfizer Australia Pty Ltd

ZAVICEFTA (powder for injection) is now also indicated for the treatment of the following infections in infants and paediatric patients (≥ 3 months to < 18 years) (see sections 4.4 Special warnings and precautions for use and 5.1 Pharmacodynamic properties):

  • Complicated intra-abdominal infection (cIAI) in combination with metronidazole.
  • Complicated urinary tract infection (cUTI) including pyelonephritis

BRAFTOVI priority review

Evaluation commenced: 21 Sep 2020

Registration decision: 13 May 2021

Date registered: 17 May 2021

Approval time: 148 (255 working days)

encorafenib

Pierre Fabre Australia Pty Ltd

Colorectal Cancer

BRAFTOVI (hard capsule), in combination with cetuximab, is now also indicated for the treatment of adult patients who have metastatic colorectal cancer (mCRC) with a BRAF V600E mutation as detected by a validated test, and who have received prior systemic therapy.

OPDIVO priority review

Evaluation commenced: 21 Sep 2020

Registration decision: 7 May 2021

Date registered: 11 May 2021

Approval time: 142 (255 working days)

nivolumab

Bristol-Myers Squibb Australia Pty Ltd

Malignant Pleural Mesothelioma (MPM)

OPDIVO (concentrate solution for infusion), in combination with ipilimumab, is now also indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.

TRELEGY ELLIPTA

Evaluation commenced: 29 May 2020

Registration decision: 6 May 2021

Date registered: 10 May 2021

Approval time: 198 (255 working days)

fluticasone furoate; umeclidinium bromide; vilanterol trifenatate

GlaxoSmithKline Australia Pty Ltd

Asthma

TRELEGY ELLIPTA (powder for inhalation) is now also indicated for the maintenance treatment of asthma in adult patient who are not adequately controlled with a combination of inhaled corticosteroid and a longacting beta2-agonist.

WINGLORE, YERVOY priority review

Evaluation commenced: 21 Sep 2020

Registration decision: 7 May 2021

Date registered: 10 May 2021

Approval time: 142 (255 working days)

ipilimumab

Bristol-Myers Squibb Australia Pty Ltd

Malignant Pleural Mesothelioma (MPM)

YERVOY/WINGLORE (concentrate solution for infusion), in combination with nivolumab, is now also indicated for the first-line treatment of patients with unresectable malignant pleural mesothelioma.

RINVOQ

Evaluation commenced: 30 Jun 2020

Registration decision: 6 May 2021

Date registered: 7 May 2021

Approval time: 191 (255 working days)

upadacitinib hemihydrate

Abbvie Pty Ltd

Psoriatic Arthritis

RINVOQ (tablet) is now also indicated for the treatment of moderate to severe active psoriatic arthritis in adult patients who have responded inadequately to, or are intolerant to one or more DMARDs. RINVOQ may be used as monotherapy or in combination with a non-biological DMARD.

Ankylosing Spondylitis

RINVOQ is now also indicated for the treatment of adults with active ankylosing spondylitis.

April 2021

TAGRISSO priority review

Evaluation commenced: 21 Sep 2020

Registration decision: 20 Apr 2021

Date registered: 22 Apr 2021

Approval time: 141 (255 working days)

osimertinib mesilate

AstraZeneca Pty Ltd

TAGRISSO (tablet) is now also indicated as adjuvant therapy after tumour resection in patients with non-small cell lung cancer (NSCLC) whose tumours have activating epidermal growth factor receptor (EGFR) mutations, as detected by a validated test.

EPCLUSA

Evaluation commenced: 2 Mar 2020

Registration decision: 9 Apr 2021

Date registered: 13 Apr 2021

Approval time: 208 (255 working days)

sofosbuvir; velpatasvir

Gilead Sciences Pty Ltd

EPCLUSA (tablet) is now also indicated for the treatment of chronic hepatitis C virus (HCV) infection (genotype 1, 2, 3, 4, 5 or 6) in adults and paediatric patients 12 years of age and older and weighing 30 kg or more.,(see 4.2 Dose and method of administration section for the recommended regimens for different patient subgroups).

March 2021

LYNPARZA

Evaluation commenced: 31 Mar 2020

Registration decision: 19 Mar 2021

Date registered: 23 Mar 2021

Approval time: 240 (255 working days)

olaparib

AstraZeneca Pty Ltd

Prostate cancer

LYNPARZA (tablet) is now also indicated as monotherapy for the

  • treatment of adult patients with BRCA-mutated (germline and/or somatic) metastatic castration-resistant prostate cancer who have progressed following prior therapy that included a new hormonal agent. BRCA mutation status should be determined by an experienced laboratory using a validated test method.

VAXIGRIP TETRA

Evaluation commenced: 31 Mar 2020

Registration decision: 18 Mar 2021

Date registered: 23 Mar 2021

Approval time: 194 (255 working days)

influenza virus haemagglutinin

Sanofi-Aventis Australia Pty Ltd

VAXIGRIP TETRA (suspension for injection) is now also indicated 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 for:

  • passive protection of infant(s) from birth to less than 6 months of age following vaccination of pregnant women (see Sections 4.2 Dose and method of administration, 4.4 Special warnings and precautions for use, 4.6 Fertility, pregnancy and lactation and 5.1 Pharmacodynamic properties - clinical trials).

VIMPAT

Evaluation commenced: 30 Apr 2020

Registration decision: 12 Mar 2021

Date registered: 22 Mar 2021

Approval time: 196 (255 working days)

lacosamide

UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

VIMPAT (solution for inejction, oral solution, tablet) is now also indicated as add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older

XOLAIR

Evaluation commenced: 31 Jan 2020

Registration decision: 12 Mar 2021

Date registered: 18 Mar 2021

Approval time: 187 (255 working days)

omalizumab

Novartis Pharmaceuticals Australia Pty Ltd

Chronic rhinosinusitis with nasal polyps (CRSwNP)

XOLAIR (solution for injection, powder for injection with diluent) is now also indicated as add?on treatment in adult patients (18 years of age and above) for the treatment of severe CRSwNP with inadequate response to intranasal corticosteroids. Recommended dosing is determined by serum immunoglobulin E levels and body weight corresponding to the recommended dose range in the Product Information (see Section 4.2 DOSE AND METHOD OF ADMINISTRATION).

FASLODEX

Evaluation commenced: 2 Jun 2020

Registration decision: 11 Mar 2021

Date registered: 15 Mar 2021

Approval time: 173 (175 working days)

fulvestrant

AstraZeneca Pty Ltd

FASLODEX (solution for injection) is now also indicated for the treatment of postmenopausal women with:

  • hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer who have not been previously treated with endocrine therapy.
  • HR positive, locally advanced or metastatic breast cancer who have progressive disease following prior endocrine (anti-oestrogen or aromatase inhibitor) therapy.

LYNPARZA

Evaluation commenced: 2 Mar 2020

Registration decision: 4 Mar 2021

Date registered: 10 Mar 2021

Approval time: 225 (255 working days)

olaparib

AstraZeneca Pty Ltd

LYNPARZA (tablet) in combination with bevacizumab is now also indicated for the:

  • maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either:
    • a deleterious or suspected deleterious BRCA mutation (germline or somatic), and/or
    • genomic instability

HRD status should be determined by an experienced laboratory using a validated test method.

Adenocarcinoma of the pancreas

LYNPARZA is now also indicated as monotherapy for the:

  • maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Germline BRCA mutation (gBRCAm) status should be determined by an experienced laboratory using a validated test method.

KESIMPTA

Evaluation commenced: 30 Mar 2020

Registration decision: 3 Mar 2021

Date registered: 4 Mar 2021

Approval time: 189 (255 working days)

ofatumumab

Novartis Pharmaceuticals Australia Pty Ltd

KESIMPTA (solution for injection) is now also indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and reduce the frequency of relapse (refer to section 5.1).

February 2021

BAVENCIO priority review

Evaluation commenced: 24 Aug 2020

Registration decision: 17 Feb 2021

Date registered: 24 Feb 2021

Approval time: 120 (255 working days)

avelumab

Merck Healthcare Pty Ltd

BAVENCIO (concentrated solution for intravenous infusion) is indicated for the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) whose disease has not progressed with first-line platinum-based induction chemotherapy.

CABENUVA

Evaluation commenced: 31 Oct 2019

Registration decision: 19 Feb 2021

Date registered: 23 Feb 2021

Approval time: 231 (255 working days)

cabotegravir; rilpivirine

ViiV Healthcare Pty Ltd

New combination

CABENUVA (suspension for injection) is indicated for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies per mL) and have no known or suspected resistance to either cabotegravir or rilpivirine (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials).

OPDIVO

Evaluation commenced: 31 Mar 2020

Registration decision: 17 Feb 2021

Date registered: 22 Feb 2021

Approval time: 174 (255 working days)

nivolumab

Bristol-Myers Squibb Australia Pty Ltd

Oesophageal Squamous Cell Carcinoma (OSCC)

OPDIVO (concentrated solution for IV infusion), as monotherapy, is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma after prior fluoropyrimidine and platinum based chemotherapy.

FYCOMPA

Evaluation commenced: 2 Jan 2020

Registration decision: 11 Feb 2021

Date registered: 16 Feb 2021

Approval time: 197 (255 working days)

perampanel hemisesquihydrate

Eisai Australia Pty Ltd

FYCOMPA (oral suspension, tablet) is indicated for the adjunctive treatment of:

  • Partial-onset seizures (POS) with or without secondarily generalised seizures in patients from 4 years of age with epilepsy.
  • Primary generalised tonic-clonic seizures (PGTCS) in patients from 7 years of age with idiopathic generalised epilepsy.

OLUMIANT

Evaluation commenced: 2 Jan 2020

Registration decision: 3 Feb 2021

Date registered: 11 Feb 2021

Approval time: 216 (255 working days)

baricitinib

Eli Lilly Australia Pty Ltd

Atopic Dermatitis

OLUMIANT (tablet) is now also indicated for the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy.

ALUNBRIG

Evaluation commenced: 31 Mar 2020

Registration decision: 4 Feb 2021

Date registered: 10 Feb 2021

Approval time: 165 (255 working days)

brigatinib

Takeda Pharmaceuticals Australia Pty Ltd

ALUNBRIG (tablet) is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).

January 2021

TREMFYA

Evaluation commenced: 18 Dec 2019

Registration decision: 21 Jan 2021

Date registered: 29 Jan 2021

Approval time: 210 (255 working days)

guselkumab

Janssen-Cilag Pty Ltd

Plaque psoriasis

TREMFYA (tablet) is now also indicated for the treatment of adult patients with active psoriatic arthritis, who have had an inadequate response to, or are intolerant to prior DMARD therapy.

DESCOVY

Evaluation commenced: 31 Jan 2020

Registration decision: 7 Jan 2021

Date registered: 14 Jan 2021

Approval time: 191 (255 working days)

emtricitabine; tenofovir alafenamide fumarate

Gilead Sciences Pty Ltd

Treatment of HIV-1 Infection

DESCOVY (tablet) is now also indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 25kg. The patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of DESCOVY (see section 5.1 Pharmacodynamic properties).

HIV-1 Pre-Exposure Prophylaxis

DESCOVY is now also indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex.

OFEV, VARGATEF

Evaluation commenced: 3 Jan 2020

Registration decision: 23 Dec 2020

Date registered: 5 Jan 2021

Approval time: 223 (255 working days)

nintedanib esilate

Boehringer Ingelheim Pty Ltd

OFEV, VARGATEF (soft capsule) are now also indicated for the treatment of other chronic fibrosing Interstitial Lung Diseases (ILDs) with a progressive phenotype.