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

22 May 2018

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


Registration of new or extended uses of registered medicines, 2018

Previous years

2017 2016

April 2018

SPIRIVA RESPIMAT; SRIVASSO RESPIMAT; ESOVYND RESPIMAT; FAVINT RESPIMAT

Evaluation commenced: 31 May 2017

Registration decision: 26 Apr 2018

Date registered: 30 Apr 2018

Approval time: 190 working days (255)

Tiotropium bromide monohydrate

Boehringer Ingelheim Pty Ltd

Tiotropium bromide monohydrate solution for inhalation cartridge is now indicated as an add-on maintenance bronchodilator treatment in children 6-11 years of age and adolescents in moderate to severe asthma.

OPDIVO priority review

Evaluation commenced: 23 Oct 2017

Registration decision: 6 Feb 2018

Date registered: 24 Apr 2018

Approval time: 124 working days (255)

nivolumab

Bristol-Myers Squibb Australia Pty Ltd

OPDIVO, as monotherapy, is now also indicated for the treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection

MENACTRA

Evaluation commenced: 31 May 2017

Registration decision: 9 Apr 2018

Date registered: 13 Apr 2018

Approval time: 177 working days (255)

meningococcal [groups A, C,Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine)

Sanofi-Aventis Australia Pty Ltd

MENACTRA solution for intramuscular injection is now also indicated for active immunisation of individuals 9 months through to 55 years of age for the prevention of invasive meningococcal disease caused by N meningitides serogroups A,C,Y and W135.

LATUDA

Evaluation commenced: 31 Mar 2017

Registration decision: 4 Apr 2018

Date registered: 5 Apr 2018

Approval time: 231 working days (255)

lurasidone hydrochloride

Servier Laboratories Australia Pty Ltd

Latuda is indicated for the treatment of schizophrenia in adolescents (aged 13 to 17 years).

March 2018

AZILECT-RASAGILINE

Evaluation commenced: 29 Jun 2017

Registration decision: 28 Mar 2018

Date registered: 22 Mar 2018

Approval time: 135 working days (255)

rasagiline

Teva Pharma Australia Pty Ltd

Azilect-Rasagiline is now also indicated as adjunct therapy to dopamine agonist or to levodovap.

GENVOYA

Evaluation commenced: 31 Mar 2017

Registration decision: 28 Mar 2018

Date registered: 20 Mar 2018

Approval time: 221 working days (255)

tenofovir alafenamide fumarate; emtricitabine; elvitegravir; cobicistat

Gilead Sciences Pty Ltd

Genvoya is now also indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 25kg.

DURATOCIN

Evaluation commenced: 28 Feb 2017

Registration decision: 16 Mar 2018

Date registered: 16 Mar 2018

Approval time: 219 working days (255)

carbetocin

Ferring Pharmaceuticals Pty Ltd

Duratocin is now also indicated for the treatment of the prevention of uterine atony and excessive bleeding following delivery of the infant by emergency caesarean section or vaginal delivery. Duratocin must be administered after delivery of the infant.

XEOMIN

Evaluation commenced: 28 Apr 2017

Registration decision: 15 Mar 2018

Date registered: 15 Mar 2018

Approval time: 180 working days (255)

incobotulinum toxin A

Merz Australia Pty Ltd

Xeomin is now also indicated for the treatment of:

  • Spasticity of upper limb
  • Upper facial lines
    • Lateral periorbital lines (crow's feet)
    • Horizontal forehead lines

DYSPORT

Evaluation commenced: 31 Mar 2017

Registration decision: 2 Mar 2018

Date registered: 13 Mar 2018

Approval time: 194 working days (255)

clostridium botulinum type A toxin - haemagglutinin complex

Ispen Pty Ltd

Dysport is now also indicated for the symptomatic treatment of:

  • focal spasticity affecting the upper limbs in adults.
  • focal spasticity affecting the lower limb in adults.
  • lower limb focal spasticity in children aged 2 years of age or older.

SPRYCEL orphan drug

Evaluation commenced: 28 Feb 2017

Registration decision: 2 Mar 2018

Date registered: 9 Mar 2018

Approval time: 212 working days (255)

dasatinib

Bristol-Myers Squibb Australia Pty Ltd

Sprycel is now also indicated for the treatment of adults aged 18 years or over with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.

February 2018

OPDIVO

Evaluation commenced: 31 Jan 2017

Registration decision: 6 Feb 2018

Date registered: 9 Feb 2018

Approval time: 186 working days (255)

nivolumab

Bristol-Myers Squibb Australia Pty Ltd

Opdivo, as monotherapy, is now also indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. The approval of this indication is based on objective response rate and duration of response in a single arm study.

LEFLUNOMIDE GENERICHEALTH

Evaluation commenced: 27 Nov 2017

Registration decision: 1 Feb 2018

Date registered: 6 Feb 2018

Approval time: 44 working days (255)

leflunomide

Southern Cross Pharma Pty Ltd

Leflunomide Generichealth is now also indicated for the treatment of active psoriatic arthritis. Leflunomide Generichealth is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. The combined use of Leflunomide Generichealth with other Disease Modifying Anti-Rheumatic Drugs (DMARDs) has not been adequately studied.

RIXADONE

Evaluation commenced: 8 Aug 2017

Registration decision: 30 Jan 2018

Date registered: 5 Feb 2018

Approval time: 124 working days (255)

risperidone

Alphapharm Pty Ltd

Generic medicine

Rixadone is now also indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type.

AFLURIA QUAD

Evaluation commenced: 3 Jan 2017

Registration decision: 1 Feb 2018

Date registered: 2 Feb 2018

Approval time: 200 working days (255)

inactivated quadrivalent influenza vaccine (split virion)

Seqirus Pty Ltd

Afluria Quad is now also indicated for the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine, in persons aged 5-17 years.

January 2018

ALECENSA orphan drugpriority review

Evaluation commenced: 7 Sep 2017

Registration decision: 30 Jan 2018

Date registered: 30 Jan 2018

Approval time: 98 working days (255*)

alectinib hydrochloride

Roche Products Pty Limited

Alecensa is now also indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

*Additional business target timeframe = 150

VYVANSE

Evaluation commenced: 30 Jun 2016

Registration decision: 22 Jan 2018

Date registered: 24 Jan 2018

Approval time: 242 working days (255)

lisdexamfetamine dimesilate

Shire Australia Pty Ltd

Vyvanse is now also indicated for the treatment of moderate to severe Binge Eating Disorder (BED) in adults when nonpharmacological treatment is unsuccessful or unavailable. Treatment should be commenced and managed by a psychiatrist.

REVLIMID

Evaluation commenced: 31 Mar 2017

Registration decision: 17 Jan 2018

Date registered: 19 Jan 2018

Approval time: 162 working days (255)

lenalidomide

Celgene Pty Ltd

Revlimid is now also indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

TRELEGY ELLIPTA

Evaluation commenced: 28 Feb 2017

Registration decision: 9 Jan 2018

Date registered: 16 Jan 2018

Approval time: 192 working days (255)

fluticasone furoate, umeclidinium bromide, vilanterol trifenatate

GlaxoSmithKline Australia Pty Ltd

Trelegy Ellipta is indicated for the maintenance treatment of adults with moderate to severe chronic obstructive pulmonary disease (COPD) who require treatment with long-acting muscarinic receptor antagonists (LAMA), long-acting β2-adrenergic receptor agonists (LABA), and an inhaled corticosteroid (ICS). Trelegy Ellipta is not indicated for the initiation of therapy in COPD.

ORENCIA

Evaluation commenced: 10 Jan 2017

Registration decision: 10 Jan 2018

Date registered: 12 Jan 2018

Approval time: 208 working days (255)

abatacept (rch)

Bristol-Myers Squibb Australia Pty Ltd

Orencia is now also indicated for the treatment of active psoriatic arthritis (PsA) in adults when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Orencia can be used with or without non-biologic DMARDs.

KEYTRUDA

Evaluation commenced: 28 Feb 2017

Registration decision: 9 Jan 2018

Date registered: 11 Jan 2018

Approval time: 182 working days (255)

pembrolizumab (rch)

Merck Sharp & Dohme (Australia) Pty Ltd

Keytruda is now also indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

  • are not eligible for cisplatin-containing therapy. This indication is approved based on overall response rate and duration of response. Improvements in overall survival, progression-free survival, or health-related quality of life have not been established; or
  • have received platinum-containing chemotherapy

VICTOZA

Evaluation commenced: 1 Feb 2017

Registration decision: 5 Jan 2018

Date registered: 8 Jan 2018

Approval time: 193 working days (255)

liraglutide (rys)

Novo Nordisk Pharmaceuticals Pty Ltd

Victoza is now also indicated for:

  • Glycaemic control: Victoza is indicated as an adjunct to diet and exercise for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control as monotherapy when metformin is contraindicated or is not tolerated.
  • Prevention of cardiovascular events: In patients where Victoza is indicated to improve glycaemic control, Victoza is indicated to reduce the risk of cardiovascular events in those at high cardiovascular risk, as an adjunct to standard of care therapy.

SAXENDA

Evaluation commenced: 1 Feb 2017

Registration decision: 5 Jan 2018

Date registered: 8 Jan 2018

Approval time: 193 working days (255)

liraglutide (rys)

Novo Nordisk Pharmaceuticals Pty Ltd

Saxenda is now also indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

  • ≥ 30 kg/m2 (obese); or
  • ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.

AFINITOR orphan drug

Evaluation commenced: 31 Jan 2017

Registration decision: 22 Dec 2017

Date registered: 3 Jan 2018

Approval time: 182 working days (255)

everolimus

Novartis Pharmaceuticals Australia Pty Ltd

Afinitor is now also indicated for the adjunctive treatment of patients aged 2 years and older with Tuberous Sclerosis Complex (TSC) and associated refractory seizures.