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

1 April 2020

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, 2020

Previous years

2019 2018 2017 2016

March 2020

ACTEMRA

Evaluation commenced: 22 Feb 2019

Registration decision: 18 Mar 2020

Date registered: 24 Mar 2020

Approval time: 242 working days (255)

tocilizumab

Roche Products Pty Ltd

Subcutaneous formulation

ACTEMRA (solution for injection) is now also indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older.

ACTEMRA IV and SC can be given alone or in combination with methotrexate (MTX).

AKYNZEO IV

Evaluation commenced: 3 Jun 2019

Registration decision: 13 Mar 2020

Date registered: 13 Mar 2020

Approval time: 172 working days (255)

fosnetupitant chloride hydrochloride

Mundipharma Pty Ltd

New Combination

AKYNZEO IV (powder for injection) is indicated for:

  • The prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.
  • The prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.

FIASP, FIASP FLEXTOUCH, FIASP PENFILL

Evaluation commenced: 1 Apr 2019

Registration decision: 11 Mar 2020

Date registered: 13 Mar 2020

Approval time: 190 working days (255)

insulin aspart (rys)

Novo Nordisk Pharmaceuticals Pty Ltd

FIASP, FIASP FLEXTOUCH, FIASP PENFILL (solution for injection) is now also indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

RYZODEG 70/30 FLEXTOUCH, RYZODEG 70/30 PENFILL

Evaluation commenced: 2 Jan 2019

Registration decision: 10 Mar 2020

Date registered: 11 Mar 2020

Approval time: 250 working days (255)

insulin degludec (rys), insulin aspart (rys)

Novo Nordisk Pharmaceuticals Pty Ltd

RYZODEG 70/30 FLEXTOUCH, RYZODEG 70/30 PENFILL (solution for injection) are now also indicated for use in diabetes mellitus in patients aged 6 years and older.

TALTZ

Evaluation commenced: 1 Apr 2019

Registration decision: 6 Mar 2020

Date registered: 11 Mar 2020

Approval time: 159 working days (255)

ixekizumab

Eli Lilly Australia Pty Ltd

Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)

TALTZ (solution for injection) is now also indicated for the treatment of active ankylosing spondylitis in adult patients.

February 2020

TECENTRIQ

Evaluation commenced: 1 Apr 2019

Registration decision: 14 Feb 2020

Date registered: 19 Feb 2020

Approval time: 194 working days (255)

atezolizumab

Roche Products Pty Ltd

TECENTRIQ (concentrated solution for injection), in combination with nab-paclitaxel and carboplatin, is now also indicated for first-line treatment of patients with metastatic non-squamous NSCLC who do not have tumour EGFR or ALK genomic aberrations.

VENCLEXTA, VENCLEXTA STARTING PACK orphan drugprovisional registration

Evaluation commenced: 31 Oct 2019

Registration decision: 11 Feb 2020

Date registered: 14 Feb 2020

Approval time: 67 working days (255)

venetoclax

Abbvie Pty Ltd

Acute Myeloid Leukaemia

VENCLEXTA (film-coated tablet), as part of combination therapy, is now also indicated for the treatment of newly diagnosed adult patients with Acute Myeloid Leukaemia (AML) who are ineligible for intensive chemotherapy.

This medicine has provisional approval in Australia for the treatment of newly diagnosed patients with AML who are ineligible for intensive chemotherapy. The decision to approve this indication has been made on the basis of interim data (overall response rate and duration of response). Continued approval of this indication depends on verification and description of benefit in confirmatory trials.

FOSTAIR

Evaluation commenced: 31 Oct 2018

Registration decision: 20 Jan 2020

Date registered: 12 Feb 2020

Approval time: 194 working days (255)

beclometasone dipropionate; formoterol (eformoterol) fumarate dihydrate

Emerge Health Pty Ltd

New Combination
Asthma

FOSTAIR (solution for inhalation) is indicated in adults (18 years and older) in the regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:

  • patients not adequately controlled with inhaled corticosteroids (ICS) and 'as needed' inhaled rapid-acting beta2-agonist or
  • patients already adequately controlled on both ICS and long-acting beta2-agonists (LABA).
COPD

Symptomatic treatment of adults with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

VENCLEXTA, VENCLEXTA STARTING PACK orphan drugprovisional registration

Evaluation commenced: 31 Jan 2019

Registration decision: 3 Feb 2020

Date registered: 11 Feb 2020

Approval time: 227 working days (255)

venetoclax

Abbvie Pty Ltd

Acute Myeloid Leukaemia

VENCLEXTA (film-coated tablet), as part of combination therapy, is now also indicated for the treatment of newly diagnosed adult patients with Acute Myeloid Leukaemia (AML) who are ineligible for intensive chemotherapy.

This medicine has provisional approval in Australia for the treatment of newly diagnosed patients with AML who are ineligible for intensive chemotherapy. The decision to approve this indication has been made on the basis of interim data (overall response rate and duration of response). Continued approval of this indication depends on verification and description of benefit in confirmatory trials.

HADLIMA

Evaluation commenced: 31 May 2019

Registration decision: 28 Jan 2020

Date registered: 6 Feb 2020

Approval time: 164 working days (255)

adalimumab

Samsung Bioepis AU Pty Ltd

Juvenile Idiopathic Arthritis
Polyarticular Juvenile Idiopathic Arthritis

HADLIMA (solution for injection) in combination with methotrexate is now also indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying antirheumatic drugs (DMARDs). HADLIMA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Enthesitis-Related Arthritis

HADLIMA is now also indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.

Psoriatic Arthritis

HADLIMA is now also indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.

Ankylosing Spondylitis

HADLIMA is now also indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Crohn's Disease in Adults and Children (6 years and older)

HADLIMA is now also indicated for the treatment of moderate to severe Crohn's disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;

  • who have had an inadequate response to conventional therapies or,
  • who have lost response to or are intolerant to infliximab.
Ulcerative Colitis

HADLIMA is now also indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time.

Psoriasis in Adults and Children

HADLIMA is now also indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. HADLIMA is now also indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.

Hidradenitis Suppurativa in Adults and Adolescents (from 12 years of age)

HADLIMA is now also indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.

Uveitis

HADLIMA is now also indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

January 2020

CEQUA

Evaluation commenced: 28 Feb 2019

Registration decision: 28 Jan 2020

Date registered: 31 Jan 2020

Approval time: 203 working days (255)

ciclosporin

Sun Pharma ANZ Pty Ltd

CEQUA (eye drops) is indicated to increase tear production in patients with moderate to severe keratoconjunctivitis sicca (dry eye) where prior use of artificial tears has not been sufficient.