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Prescription medicines: new or extended uses, or new combinations of registered medicines
14 January 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.
Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market
Priority review: involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
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
November 2020
IMFINZI
Evaluation commenced: 2 Dec 2019
Registration decision: 20 Nov 2020
Date registered: 25 Nov 2020
Approval time: 221 working days (225)
durvalumab
AstraZeneca Pty Ltd
Small cell lung cancer (SCLC)
IMFINZI (solution for injection) in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
ANDROFEME, ANDROFORTE
Evaluation commenced: 2 Dec 2019
Registration decision: 17 Nov 2020
Date registered: 23 Nov 2020
Approval time: 192 working days (255)
testosterone
Lawley Pharmaceuticals Pty Ltd
ANDROFORTE 5 (cream) is indicated for use as testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.
ANDROFEME 1 (cream) is indicated for the treatment of hypoactive sexual desire dysfunction (HSDD) in postmenopausal women.
Therapeutic intervention with ANDROFEME 1 should only be initiated in women following failure of appropriate education and correction of modifiable biopsychosocial factors (which may include neuroendocrine imbalance, physical ill health or disease, interpersonal difficulties, psychological distress or specific cultural or religious beliefs), according to the International Society for the Study of Women's Sexual Health (ISSWSH) process of care (see Figure 1).
STELARA
Evaluation commenced: 31 Oct 2019
Registration decision: 12 Nov 2020
Date registered: 16 Nov 2020
Approval time: 215 working days (255)
ustekinumab
Janssen-Cilag Pty Ltd
Plaque Psoriasis - Paediatric population, 6 years and older
STELARA (solution for injection) is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from 6 years of age who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
IMBRUVICA
Evaluation commenced: 2 Mar 2020
Registration decision: 16 Oct 2020
Date registered: 10 Nov 2020
Approval time: 158 working days (255)
ibrutinib
Janssen-Cilag Pty Ltd
IMBRUVICA (tablet) as a single agent or in combination with rituximab or obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia/small lymphocytic leukemia (CLL/SLL). Can be used in patients with deletion 17p.
FORXIGA
Evaluation commenced: 18 Dec 2019
Registration decision: 5 Nov 2020
Date registered: 5 Nov 2020
Approval time: 200 working days (255)
dapagliflozin propanediol monohydrate
AstraZeneca Pty Ltd
Heart failure
FORXIGA (tablet)is indicated in adults for the treatment of symptomatic heart failure with reduced ejection fraction, as an adjunct to standard of care therapy (see section 5.1 Pharmacodynamic properties).
October 2020
ERLYAND, JANSSEN APALUTAMIDE
Evaluation commenced: 30 Sep 2019
Registration decision: 15 Sep 2020
Date registered: 22 Oct 2020
Approval time: 218 working days (255)
apalutamide
Janssen-Cilag Pty Ltd
ERLYAND, JANSSEN APALUTAMIDE (film coated tablet) is now also indicated for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
ENERZAIR BREEZHALER
Evaluation commenced: 31 Jul 2019
Registration decision: 9 Oct 2020
Date registered: 20 Oct 2020
Approval time: 226 working days (255)
glycopyrronium bromide; indacaterol acetate; mometasone furoate
Novartis Pharmaceuticals Australia Pty Ltd
New Combination
ENERZAIR BREEZHALER (hard capsule) is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.
DOVATO
Evaluation commenced: 2 Jan 2020
Registration decision: 2 Oct 2020
Date registered: 13 Oct 2020
Approval time: 170 working days (255)
dolutegravir sodium; lamivudine
ViiV Healthcare Pty Ltd
DOVATO (film coated tablet) is now also indicated to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to the integrase inhibitor class or lamivudine (see section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials).
RIMYCIN 
Evaluation commenced: 30 Apr 2020
Registration decision: 15 Sep 2020
Date registered: 8 Oct 2020
Approval time: 97 working days (255)
rifampicin
Alphapharm Pty Ltd
Buruli Ulcer
RIMYCIN (hard capsule) is now also indicated for the treatment of Mycobacterium ulcerans infections (Buruli ulcer). Rifampicin must be used in combination with another anti-Mycobacterium ulcerans antibiotic.
September 2020
KEYTRUDA
Evaluation commenced: 2 Dec 2019
Registration decision: 22 Sep 2020
Date registered: 28 Sep 2020
Approval time: 161 working days (255)
pembrolizumab
Merck Sharp & Dohme (Australia) Pty Ltd
Head and Neck Squamous Cell Cancer (HNSCC)
KEYTRUDA® (powder for injection, concentrated solution for injection), as monotherapy or in combination with platinum and 5-fluorouracil (5-FU) chemotherapy, is now also indicated for the first-line treatment of patients with metastatic or unresectable recurrent HNSCC, and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.
KEYTRUDA® is now also indicated as monotherapy for the treatment of patients with metastatic or unresectable recurrent HNSCC with disease progression on or after platinum-containing chemotherapy and whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by a validated test.
COSENTYX
Evaluation commenced: 4 Dec 2019
Registration decision: 10 Sep 2020
Date registered: 17 Sep 2020
Approval time: 146 working days (255)
secukinumab
Novartis Pharmaceuticals Australia Pty Ltd
COSENTYX (powder for injection; solution for injection) is now also indicated for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI change, who have had an inadequate response to, or are intolerant to, NSAIDs.
TECENTRIQ
Evaluation commenced: 2 Mar 2020
Registration decision: 28 Aug 2020
Date registered: 8 Sep 2020
Approval time: 124 working days (255)
atezolizumab
Roche Products Pty Ltd
Hepatocellular carcinoma
TECENTRIQ (concentrated solution for injection), in combination with bevacizumab, is now also indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.
July 2020
ATECTURA BREEZHALER
Evaluation commenced: 31 Jul 2019
Registration decision: 16 Jul 2020
Date registered: 21 Jul 2020
Approval time: 194 working days (255)
indacaterol acetate; mometasone furoate
Novartis Pharmaceuticals Australia Pty Ltd
New Combination
ATECTURA BREEZHALER (microgram powder for inhalation in hard capsule with inhaler) is indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older where use of a combination of long-acting beta2-agonist and inhaled corticosteroid is appropriate:
- patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonists or
- patients not adequately controlled with long-acting beta2-agonists and low dose of inhaled corticosteroids and 'as needed' inhaled short-acting beta2-agonists.
DELSTRIGO
Evaluation commenced: 31 May 2019
Registration decision: 13 Jul 2020
Date registered: 21 Jul 2020
Approval time: 197 working days (255)
doravirine; lamivudine; tenofovir disoproxil fumarate
Merck Sharp & Dohme (Australia) Pty Ltd
DELSTRIGO (film coated tablet) is now indicated for the treatment of HIV-1 infection in adult patients:
- With no prior antiretroviral history, OR
- To replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine, lamivudine, or tenofovir.
DYSPORT A
Evaluation commenced: 31 Jul 2019
Registration decision: 14 Jul 2020
Date registered: 21 Jul 2020
Approval time: 199 working days (255)
clostridium botulinum type a toxin haemagglutinin complex
Ipsen Pty Ltd
DYSPORT (powder for injection) is now also indicated for symptomatic treatment of focal spasticity of upper limbs in children aged 2 years and older.
PIFELTRO
Evaluation commenced: 31 May 2019
Registration decision: 13 Jul 2020
Date registered: 21 Jul 2020
Approval time: 197 working days (255)
doravirine
Merck Sharp & Dohme (Australia) Pty Ltd
PIFELTRO (film coated tablet) is now indicated, in combination with other antiretroviral medicinal products, for the treatment of HIV-1 infection in adult patients:
- with no prior antiretroviral treatment history, OR
- to replace the current antiretroviral regimen in those who are Virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.
TRULICITY
Evaluation commenced: 30 Sep 2019
Registration decision: 14 Jul 2020
Date registered: 15 Jul 2020
Approval time: 158 working days (255)
dulaglutide
Eli Lilly Australia Pty Ltd
Type 2 Diabetes Mellitus: reduction in risk of major adverse cardiovascular events
TRULICITY (solution for injection) is now also indicated as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have:
- established cardiovascular disease or
- multiple cardiovascular risk factors.
OPDIVO
Evaluation commenced: 31 Mar 2020
Registration decision: 9 Jul 2020
Date registered: 13 Jul 2020
Approval time: 68 working days (255)
nivolumab
Bristol-Myers Squibb Australia Pty Ltd
Non-Small Cell Lung Cancer (NSCLC)
OPDIVO (concentrated solution for injection), in combination with ipilimumab and 2 cycles of platinum-doublet chemotherapy, is now also indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations.
WINGLORE, YERVOY
Evaluation commenced: 31 Mar 2020
Registration decision: 9 Jul 2020
Date registered: 13 Jul 2020
Approval time: 68 working days (255)
ipilimumab
Bristol-Myers Squibb Australia Pty Ltd
Non-Small Cell Lung Cancer (NSCLC)
WINGLORE, YERVOY (concentrated solution for injection), in combination with nivolumab and 2 cycles of platinum-doublet chemotherapy, is now also indicated for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumour aberrations.
FENOFIBRATE SANDOZ
Evaluation commenced: 13 Dec 2019
Registration decision: 5 Feb 2020
Date registered: 7 Jul 2020
Approval time: 32 working days (45)
fenofibrate
Sandoz Pty Ltd
Generic Medicine
FENOFIBRATE SANDOZ (film coated tablet) is now also indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy.
FENOFIBRATE SANDOZ does not replace the appropriate control of blood pressure, blood glucose and blood lipids in reducing the progression of diabetic retinopathy.
SOLIRIS
Evaluation commenced: 2 Dec 2019
Registration decision: 26 Jun 2020
Date registered: 1 Jul 2020
Approval time: 115 working days (255)
eculizumab
Alexion Pharmaceuticals Australasia Pty Ltd
SOLIRIS (intravenous infusion) is indicated for the treatment of patients with:
- Paroxysmal Nocturnal Haemoglobinuria (PNH) to reduce haemolysis.
- atypical Haemolytic Uraemic Syndrome (aHUS).
- Adult patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody-positive.
SOLIRIS is not intended for acute treatment of a NMOSD relapse.
June 2020
ADACEL POLIO
Evaluation commenced: 30 Apr 2020
Registration decision: 26 Jun 2020
Date registered: 30 Jun 2020
Approval time: 40 working days (255)
diphtheria toxoid; pertactin; pertussis filamentous haemagglutinin; pertussis fimbriae 2 + 3; pertussis toxoid; poliovirus; tetanus toxoid
Sanofi-Aventis Australia Pty Ltd
ADACEL POLIO (suspension for injection) now may also be administered during pregnancy for prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the fetus.
SPRYCEL
Evaluation commenced: 16 Jul 2019
Registration decision: 25 Jun 2020
Date registered: 29 Jun 2020
Approval time: 213 working days (255)
dasatinib
Bristol-Myers Squibb Australia Pty Ltd
SPRYCEL (film-coated tablet) is now also indicated for the treatment of paediatric patients with:
- Ph+ CML in the chronic phase.
- newly diagnosed Ph+ ALL in combination with chemotherapy.
TRIMBOW
Evaluation commenced: 10 May 2019
Registration decision: 18 Jun 2020
Date registered: 24 Jun 2020
Approval time: 155 working days (255)
beclometasone dipropionate; formoterol (eformoterol) fumarate dihydrate; glycopyrronium bromide (glycopyrrolate)
Emerge Health Pty Ltd
New Combination
TRIMBOW (pressurised inhalation solution) is indicated for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA) or a combination of a LABA and a long-acting muscarinic antagonist (LAMA).
TOUJEO
Evaluation commenced: 2 Sep 2019
Registration decision: 12 Jun 2020
Date registered: 22 Jun 2020
Approval time: 170 working days (255)
insulin glargine
Sanofi-Aventis Australia Pty Ltd
TOUJEO (solution for injection) is now also indicated for the treatment of diabetes mellitus in adolescents and children 6 years of age and older.
KEYTRUDA
Evaluation commenced: 31 Jul 2019
Registration decision: 2 Jun 2020
Date registered: 12 Jun 2020
Approval time: 173 working days (255)
pembrolizumab
Merck Sharp & Dohme (Australia) Pty Ltd
Renal Cell Carcinoma
KEYTRUDA® (concentrated injection; powder for injection) in combination with axitinib, is now also indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
May 2020
REVESTIVE
Evaluation commenced: 31 May 2019
Registration decision: 26 May 2020
Date registered: 26 May 2020
Approval time: 203 working days (255)
teduglutide
Shire Australia Pty Ltd
REVESTIVE (powder for solution for injection) is now also indicated for the treatment of paediatric patients 2 year of age and above with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
SLENYTO
Evaluation commenced: 31 Jul 2019
Registration decision: 20 May 2020
Date registered: 22 May 2020
Approval time: 171 working days (175)
melatonin
RAD Data Australia Pty Ltd
SLENYTO (modified release tablet) is now indicated for the treatment of insomnia in children and adolescents aged 2-18 with Autism Spectrum Disorder (ASD) and / or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.
BIRESP SPIROMAX, DUORESP SPIROMAX
Evaluation commenced: 19 Mar 2020
Registration decision: 30 Apr 2020
Date registered: 20 May 2020
Approval time: 28 working days (45)
budesonide; formoterol (eformoterol) fumarate dihydrate
Teva Pharma Australia Pty Ltd
Generic medicine
Asthma
BIRESP SPIROMAX, DUORESP SPIROMAX (powder for inhalation) are now also indicated in adults (18 years and older) for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk and exacerbations (see Section 4.2 Dose and method of administration).
BIRESP SPIROMAX, DUORESP SPIROMAX are not indicated in children and adolescents under the age of 18 years as the 100/6 dose is not available.
STELARA
Evaluation commenced: 1 May 2019
Registration decision: 14 May 2020
Date registered: 19 May 2020
Approval time: 214 working days (255)
ustekinumab
Janssen-Cilag Pty Ltd
Ulcerative colitis
STELARA (solution for injection) is now also indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.
LIPIODOL
Evaluation commenced: 30 Apr 2019
Registration decision: 14 May 2020
Date registered: 18 May 2020
Approval time: 208 working days (255)
iodised oil
Guerbet Australia Pty Ltd
In interventional radiology
LIPIODOL (solution for injection) is now also indicated as an imaging agent for visualisation and localisation during Trans-Arterial Chemo-Embolisation (TACE) of hepatocellular carcinoma (HCC) at intermediate stage in adults (see section 4.3 -Contraindications and Section 4.4 Special Warnings and Precautions for Use).
BAVENCIO
Evaluation commenced: 1 Jul 2019
Registration decision: 4 May 2020
Date registered: 6 May 2020
Approval time: 190 working days (255)
avelumab
Merck Healthcare Pty Ltd
BAVENCIO (concentrated solution for injection) in combination with axitinib is now also indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
VENCLEXTA, VENCLEXTA STARTING PACK
Evaluation commenced: 30 Apr 2019
Registration decision: 30 Apr 2020
Date registered: 5 May 2020
Approval time: 222 working days (255)
venetoclax
Abbvie Pty Ltd
Chronic Lymphocytic Leukaemia / Small Lymphocytic Lymphoma
VENCLEXTA (film coated tablet) in combination with obinutuzumab is now also indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who are considered unfit or unsuitable for chemo-immunotherapy.
April 2020
ADCETRIS
Evaluation commenced: 2 Sep 2019
Registration decision: 24 Apr 2020
Date registered: 30 Apr 2020
Approval time: 146 working days (255)
brentuximab vedotin
Takeda Pharmaceuticals Australia Pty Ltd
Peripheral T-cell lymphoma
ADCETRIS (powder for injection) is now also indicated for the treatment of adult patients with previously untreated CD30+ peripheral T-cell lymphoma (PTCL) in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) (see 5.1 Pharmacodynamic Propertues, Clinical Trials).
DARZALEX, JANSSEN DARATUMUMAB
Evaluation commenced: 1 Jul 2019
Registration decision: 29 Apr 2020
Date registered: 30 Apr 2020
Approval time: 186 working days (255)
daratumumab
Janssen-Cilag Pty Ltd
DARZALEX (concentrated solution for injection) is now also indicated for the treatment of patients:
- with newly diagnosed multiple myeloma:
- who are eligible for autologous stem cell transplant. For use in combination with:
- bortezomib, thalidomide, and dexamethasone.
- who are eligible for autologous stem cell transplant. For use in combination with:
- who are ineligible for autologous stem cell transplant. For use in combination with:
- bortezomib, melphalan and prednisone, or
- lenalidomide and dexamethasone.
- with multiple myeloma who have received:
- at least one prior therapy. For use in combination with:
- bortezomib and dexamethasone, or
- lenalidomide and dexamethasone.
- at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent. For use as:
- monotherapy.
- at least one prior therapy. For use in combination with:
ESCITALOPRAM GH
Evaluation commenced: 27 Feb 2020
Registration decision: 3 Apr 2020
Date registered: 24 Apr 2020
Approval time: 18 working days (45)
escitalopram oxalate
Lupin Australia Pty Limited
Generic medicine
ESCITALOPRAM GH (film coated tablets) is now also indicated for:
- Treatment of social anxiety disorder (social phobia).
- Treatment of generalised anxiety disorder.
FORXIGA
Evaluation commenced: 31 May 2019
Registration decision: 15 Apr 2020
Date registered: 17 Apr 2020
Approval time: 184 working days (255)
dapagliflozin propanediol monohydrate
AstraZeneca Pty Ltd
Prevention of hospitalisation for heart failure
FORXIGA (film coated tablets) is now also indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure (see section 5.1 Pharmacodynamic properties - Clinical trials).
XIGDUO XR
Evaluation commenced: 31 May 2019
Registration decision: 15 Apr 2020
Date registered: 17 Apr 2020
Approval time: 184 working days (255)
dapagliflozin propanediol monohydrate; metformin hydrochloride
AstraZeneca Pty Ltd
Prevention of hospitalisation for heart failure
XIGDUO XR (modified release tablets) is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure.
ZERBAXA
Evaluation commenced: 4 Mar 2019
Registration decision: 31 Mar 2020
Date registered: 7 Apr 2020
Approval time: 169 working days (255)
ceftolozane sulfate; tazobactam sodium
Merck Sharp & Dohme (Australia) Pty Ltd
ZERBAXA (powder for injection) is now also indicated for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia (VAP) infections in adults suspected or proven to be caused by designated susceptible microorganisms.
OFEV, VARGATEF
Evaluation commenced: 31 May 2019
Registration decision: 1 Apr 2020
Date registered: 3 Apr 2020
Approval time: 170 working days (255)
nintedanib esilate
Boehringer Ingelheim Pty Ltd
OFEV, VARGATEF (soft capsules) are now also indicated for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
LUCENTIS
Evaluation commenced: 5 Mar 2019
Registration decision: 27 Mar 2020
Date registered: 2 Apr 2020
Approval time: 196 working days (255)
ranibizumab (rbe)
Novartis Pharmaceuticals Australia Pty Ltd
LUCENTIS (solution for injection) is now also indicated in adults for the treatment of proliferative diabetic retinopathy (PDR).
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 
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
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.