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

5 February 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

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.