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Prescription medicines and biologicals: TGA annual summary 2016

31 January 2017
cover of report

In 2016

42 New Chemical Entity (NCE) registrations

45 New or extended uses, or new combination registrations

18 Orphan Drug registrations

50 AusPAR publications

NCE registrations by year

NCE registrations by year: 2012 - 25; 2013 - 39; 2014 - 39; 2015 - 35; 2016 - 42

Introduction

The Therapeutic Goods Administration (TGA) is a part of the Health Products Regulation Group (HPRG) within the Australian Commonwealth Department of Health. TGA contributes to the protection and promotion of public health as the regulator responsible for evaluating new therapeutic goods for human use in Australia; this includes pharmaceutical medicines, complementary medicines, biological products, and medical devices. TGA supports timely access to therapeutic products that achieve better health and wellbeing, while determining that these products do not pose an unacceptable risk to the health and safety of the Australian public.

This is TGA's third Annual Summary report on the registration of prescription medicines. Once approved, these medicines are added to the Australian Register of Therapeutic Goods (ARTG) and can be lawfully supplied in Australia. This report includes details of newly-registered prescription medicines, along with those already-registered medicines that have been approved for new uses (known as an 'extension of indications') and in new combinations. For the first time, the Annual Summary also details new biologicals and Australian Public Assessment Reports (AusPARs) published online.

The 2016 registrations covered a wide therapeutic base, with new treatments for a number of diseases including cancer, multiple sclerosis and cystic fibrosis. During this period, two new first-in-class treatments were approved for ovarian cancer and high cholesterol, along with whole regimen treatment options for HIV and hepatitis C virus infection. Orphan drugs for the treatment of rare diseases were approved for haemophilia and non-small cell lung cancer. Notably, TGA saw an increased number of new registrations of immunotherapies, including monoclonal antibodies. Today, TGA's approval times for prescription medicines are comparable – and, for standard approvals, often faster – with analogous registration processes in the US and Europe. In 2016, over 80% of TGA's registrations of prescription medicines were completed on time or before the planned date, which is well within legislated maximum timeframes. In 2017, an accelerated evaluation process for certain new prescription medicines will also be introduced.

I am pleased to share the 2016 Annual Summary report. We hope this information is of use to the Australian public, healthcare professionals, government agencies, other medicines regulators, and industry as we work together towards better health outcomes for all Australians.

Adjunct Professor John Skerritt
Deputy Secretary

Therapeutic Goods Administration
Health Products Regulation Group
Department of Health

January 2017

Some innovative and 'first-in-class' new registrations

Please note that the actual indication for which each prescription medication is approved may be more specific than described in this summary. For full indications, please consult the Australian Register of Therapeutic Goods (ARTG).

BRIVIACT

Briviact (brivaracetam) is used for the treatment of seizures in patients with epilepsy. In the brain, Briviact binds to the synaptic vesicle protein 2A and inhibits presynaptic calcium channels; this in turn reduces neurotransmitter release, impedes impulse conduction across synapses, and brings about an anticonvulsant effect.

EMPLICITI

Empliciti (elotuzumab) is a human monoclonal antibody used to treat multiple myeloma. Following intravenous injection, Empliciti specifically targets the cell surface SLAMF7 (Signaling Lymphocytic Activation Molecule Family member 7) glycoprotein, which is expressed on myeloma cells and also Natural Killer (NK) cells. As a result, Empliciti facilitates the interaction of NK cells with myeloma cells to mediate the killing of the cancer through antibody-dependent cellular cytotoxicity (ADCC). Empliciti thereby works by activating the body's own immune system to attack and kill cancer cells.

ENTRESTO

Entresto is a single drug for the treatment of chronic heart failure that combines two different medications: (1) sacubitril, which controls blood volume and lowers blood pressure, and (2) valsartan, which keeps blood vessels from narrowing and improves blood flow. Entresto helps lower the risk of hospitalisation when symptoms get worse, and helps lower the risk of death from heart failure.

FARYDAK

Farydak (panobinostat) is used to treat patients with multiple myeloma, a form of blood cancer arising from plasma cells in bone marrow. Farydak is an innovative new drug that works by inhibiting the activity of enzymes known as histone deacetylases. This process slows the growth of plasma cells in multiple myeloma patients or causes these dangerous cells to die.

GENVOYA

Genvoya is a complete regimen for the treatment of HIV-1 infection, containing four different medicines combined into one pill taken daily with food: (1) elvitegravir blocks an HIV enzyme called integrase, (2) cobicistat increases the effectiveness of elvitegravir, while (3) emtricitabine and (4) tenofovir alafenamide (as fumarate) block an HIV enzyme called reverse transcriptase. By blocking enzyme activity, Genvoya prevents HIV from multiplying in the body. Genvoya also contains a new form of tenofovir, which reduces side effects.

LENVIMA

Lenvima (lenvatinib) is used to treat patients with differentiated thyroid cancer, a cancerous growth of the thyroid gland which is located in the neck and helps regulate the body's metabolism. Elevated levels of the protein vascular endothelial growth factor (VEGF), which stimulates the growth of new blood vessels, have been noted in thyroid tumours. Lenvima works as an anti-cancer drug by blocking the activation of VEGF receptors by VEGF, which in turn reduces the growth of cancer cells.

LYNPARZA

Lynparza (olaparib) is used to treat patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer with a mutation in their BRCA genes. These genes play a role in DNA repair; mutations prevent this repair, which leads to uncontrolled cell growth and cancer. By inhibiting this defective repair process, Lynparza allows DNA to repair normally, and for cell growth to remain controlled. Lynparza is used with a companion diagnosti genetic test to identify BRCA mutations in suitable patients.

OPDIVO

Opdivo (nivolumab) is a human monoclonal antibody used to treat patients with melanoma, non-small cell lung cancer, or advanced clear cell renal cell carcinoma. It is a form of cancer immunotherapy, which is a new way to treat cancer through the stimulation of an immune response. Opdivo works as a checkpoint inhibitor, blocking a signal that would have otherwise prevented activated T cells from secreting cytokines and attacking the cancer. The immune system is thus able to help clear the cancer from the body.

ORKAMBI

Orkambi is a combination drug available in a single pill for the treatment of cystic fibrosis in people who have two copies of the F508del mutation in the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR) protein. The F508del genetic mutation on chromosome 7 causes the CFTR protein to misfold; cells then destroy these defective proteins soon after they are made, which disrupts how water and chloride are transported in the body. In Orkambi, lumacaftor increases the number of CFTR proteins trafficked to the cell surface, while ivacaftor increases the probability the defective channel will open and allow chloride ions to pass through.

PRALUENT

Praluent (alirocumab) is a human monoclonal antibody injected under the skin and used to treat patients who are unable to control their low-density lipoprotein (LDL) cholesterol in addition to diet, exercise, and other cholesterol-lowering drugs. Praluent targets a specific protein, proprotein convertase subtilisin kexin 9 (PCSK9), to reduce the number of receptors on the liver that remove LDL cholesterol from the blood. By blocking PCSK9's ability to work, more receptors are available to remove LDL cholesterol from the blood, which thereby lowers a patient's LDL cholesterol levels.

ZEPATIER

Zepatier is a single drug for the treatment of genotype 1 and 4 chronic hepatitis C virus (HCV) infections that combines two different medications: (1) elbasvir, which prevents the transcription of the HCV RNA, and (2) grazoprevir, which blocks the action of viral replication. Zepatier provides an oral treatment option for patients with HCV infections without requiring the use of interferon.

ZINBRYTA

Zinbryta (daclizumab) is a human monoclonal antibody used to treat multiple sclerosis (MS). It works by targeting the CD25 subunit of interleukin 2 (IL-2) receptors, which are highly expressed on reactive T cells in MS patients. By stopping and preventing the inflammation caused by CD25-positive T cells, Zinbryta reduces the symptoms of MS. Zinbryta is an injection administered by the patient under the skin on a monthly basis. The long-acting nature of Zinbryta means overall fewer injections for patients.

ZYKADIA

Zykadia (ceritinib) is used to treat patients with non-small cell lung cancer (NSCLC) who have a genetic rearrangement in the anaplastic lymphoma kinase (ALK) gene. ALK gene rearrangement is found in about 2-7% of patients with NSCLC, which makes up about 85% of all lung cancer. Zykadia is an ALK tyrosine kinase inhibitor, and so blocks the proteins that promote the development of cancer cells.

Some new or extended uses for existing medicines

In addition to the approval of new prescription medicines, patients will also benefit from the approval of certain existing medicines for new or extended therapeutic uses. For full information on the indications, please consult the Australian Register of Therapeutic Goods (ARTG).

DESCOVY

Descovy (emtricitabine / tenofovir alafenamide fumarate) is a combination drug containing a new form of tenofovir (as alafenamide fumarate). The earlier emtricitabine combination containing tenofovir disoproxil fumarate has been registered since 2005 for the treatment of HIV-1 infection and pre-exposure prophylaxis (PrEP) to prevent infection. Although Descovy is not for use in PrEP, this new combination will be an improved option in the treatment of HIV because it has better renal and bone safety.

ESMYA

Ulipristal acetate has been registered since 2015 for emergency contraception.

Esmya is a new presentation of ulipristal acetate that is now also approved for the treatment of uterine fibroids in adult women of reproductive age. Previously, the treatment of uterine fibroids was with surgery.

FYCOMPA

Fycompa (perampanel as hemisesquihydrate) has been registered since 2014 for the treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.

Fycompa is now also indicated for the adjunctive treatment of primary generalised tonic-clonic seizures in adult and adolescent patients from 12 years of age with idiopathic generalised epilepsy.

HARVONI

Harvoni (ledipasvir / sofosbuvir) has been registered since 2015 for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection in adults.

Harvoni is now also indicated for the treatment of genotype 4, 5 and 6 HCV infections, and so provides more treatment options for patients with these rarer genotypes.

KALYDECO

Kalydeco (ivacaftor) has been registered since 2013 for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have a G551D or other gating (class III) mutation or an R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Kalydeco is now also indicated for the treatment of CF in patients aged 2 years and older with these genetic abnormalities. The availability of the medicine for children at a younger age is important since CF is a congenital disorder. It is now also available as granules, not only tablets.

ODEFSEY

Odefsey is a complete regimen for the treatment of HIV-1 infection, containing three different antiretroviral drugs combined into one pill taken daily with food: emtricitabine, rilpivirine, and tenofovir alafenamide.

PERJETA

Perjeta (pertuzumab) has been registered since 2013 in combination with trastuzumab and docetaxel for patients with metastatic HER2-positive breast cancer who have not received prior anti-HER2 therapy or chemotherapy for their metastatic disease.

Perjeta is now also indicated in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of patients with inflammatory or locally advanced HER2-positive breast cancer as part of a complete treatment regimen. The change means Perjeta is available to a wider group of breast cancer patients.

TARGIN

Targin (oxycodone hydrochloride / naloxone hydrochloride) has been registered since 2010 for the management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. The naloxone component is indicated for the therapy and/or prophylaxis of opioid-induced constipation.

Targin is now also indicated for second line symptomatic treatment of patients with severe to very severe idiopathic restless legs syndrome after failure of dopaminergic therapy.

TECHNIVIE

The combination drug containing paritaprevir / ritonavir / ombitasvir has been registered since 2015 for the treatment of genotype 1 chronic hepatitis C virus (HCV) infection.

Technivie is a new presentation of this combination and is now also indicated for the treatment of patients with genotype 4 HCV infection, and so provides more treatment options for patients with this rarer genotype.

TRUVADA

Truvada (emtricitabine / tenofovir disoproxil fumarate) has been registered since 2005 for the treatment of HIV-1 infected adults, in combination with other antiretroviral agents.

Truvada is now also indicated, in combination with safer sex practices, for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.

VICTOZA

Liraglutide has been registered as Victoza since 2010, in combination with metformin or a sulfonylurea, for the treatment of patients with type 2 diabetes. A second presentation in 2015 was approved for use in chronic weight management in obese or overweight patients, in conjunction with diet and exercise.

Victoza is now also indicated for combination therapy with basal insulin, with or without metformin, for the treatment of type 2 diabetes.

XIAFLEX

Xiaflex (collagenase clostridium histolyticum) has been registered since 2013 for the treatment of Dupuytren's contracture in adult patients with a palpable cord.

Xiaflex is now also indicated for treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

Paediatric uses for registered medicines

A number of existing medicines were approved for extended therapeutic uses in children in 2016. These included some orphan drugs, which are intended to treat rare diseases, and which can be extended for use in children with congenital diseases existing at or before birth.

ALPROLIX & ELOCTATE

Alprolix and Eloctate both containing the active ingredient efmoroctocog alfa have been registered since 2014 as long-acting anti-haemophilic factors in children older than 12 years and adults with haemophilia A and B, respectively.

Alprolix and Eloctate are now also indicated for use in children under the age of 12 years, which broadens their use to paediatric patients of all ages with haemophilia A or B.

REVOLADE

Revolade (eltrombopag) has been registered since 2010 for the treatment of adult patients with chronic immune thrombocytopenic purpura (ITP) who have had an inadequate response or are intolerant to corticosteroids and immunoglobulins.

Revolade is now also indicated for the treatment of paediatric patients with chronic ITP, so can now be used in a wider population base.

XOLAIR

Xolair (omalizumab) has been registered since 2002 for the management of adult and adolescent patients with moderate to severe allergic asthma.

Xolair is now also indicated for use in asthmatic children aged 6 to <12 years, which broadens its use to younger paediatric patients with severe allergic asthma.

TGA's regulatory framework for biologicals

A new regulatory framework for biologicals was introduced in 2011. A 'biological' is defined as a substance that comprises, contains, or is derived from human cells or tissue; and is represented in any way to be, or is likely to be, for therapeutic use. The regulatory changes involved transitioning some human tissues and cell-based therapies to the ARTG to be listed alongside the 'new chemical entities' (e.g. pharmaceutical prescription medicines) and 'new biological entities' (e.g. vaccines). This will assure the public of the quality of the human cell and tissue-based therapeutic goods used in Australia, and increase the visibility of the types of cells and tissues approved for use.

The Biologicals Regulatory Framework provides a comprehensive system of assessment and controls that must be completed before products are allowed to be marketed in Australia and follow-up and further controls after they are marketed. For lower risk biologicals that have undergone no or only simple processing (called 'minimal manipulation'), such as the products supplied by the tissue banks, TGA evaluates their compliance with relevant quality standards. For higher risk biologicals, such as cell therapies, TGA evaluates their compliance with relevant standards relating to quality, safety and efficacy. All manufacturers of biologicals must also show that they comply with the manufacturing principles outlined in the Australian Code of Good Manufacturing Practice (GMP) for human blood and tissues. Some examples of biologicals regulated by TGA are listed below, including their sources:

Musculoskeletal tissue, e.g. bone products:

  • Hunter New England Bone Bank
  • PlusLife
  • Metro South Hospital and Health Service T/A Queensland Bone Bank
  • South Eastern Sydney Local Health District
  • Victorian Institute of Forensic Medicine T/A Donor Tissue Bank of Victoria
  • Sydney Local Health District T/A Rachel Forster Bone Bank
  • SA Pathology
  • Johnson & Johnson Medical Pty Ltd T/A DePuy Synthes
  • Barwon Health – Bone Bank
  • Australian Biotechnologies Pty Limited

Ocular tissue, e.g. cornea:

  • South Eastern Sydney Local Health District
  • Queensland Eye Bank
  • Lions Eye Donation Service
  • Eye Bank of South Australia
  • Lions Eye Bank of Western Australia

Skin tissue, e.g. to treat severe burns:

  • Metro South Hospital and Health Service T/A Queensland Bone Bank
  • Skin (Dermis) – Johnson & Johnson Medical Pty Ltd T/A DePuy
  • Victorian Institute of Forensic Medicine T/A Donor Tissue Bank of Victoria

Cardiovascular tissue, e.g. heart valves and arteries:

  • Victorian Institute of Forensic Medicine T/A Donor Tissue Bank of Victoria
  • Metro South Hospital and Health Service T/A Queensland Heart Valve Bank
  • The Sydney Heart Valve Bank

Demineralised bone products, e.g. mixed with a carrier to make it mouldable to the defect:

  • DBX Putty
  • Grafton DBM Orthoblend
  • Grafton DBM Flex
  • Grafton Plus DBM Paste
  • Grafton DBM Matrix

Biologicals clinical trials

Some novel therapies that use biologicals have also entered clinical trials over the past two years, including the following trials approved under the clinical trial exemption (CTX) scheme:

Anti-Lewis Y gene modified T cells

A Phase I study investigating the safety and tolerability of an infusion of T lymphocytes transduced with an anti-LewisY (LeY) chimeric receptor gene in patients with solid tumours expressing LeY.

12 August 2016

Human parthenogenetic stem cell-derived neural stem cells

A Phase I study investigating the safety of human parthenogenetic-derived neural stem cells (ISC-hpNSC) when injected into patients with Parkinson's disease.

10 December 2015

Anti-GD2 gene modified T cells

A Phase I study investigating the safety and tolerability of autologous peripheral blood T cells transfected with a retroviral construct to express a GD2‐specific chimeric antigen receptor and an inducible caspase 9 (iCasp9) gene in patients with metastatic melanoma.

20 April 2015

New registrations by therapeutic area

Immunomodulators, gynaecological and cosmetic agents

ESBRIET pirfenidone

ORKAMBI lumacaftor / ivacaftor

BELKYRA deoxycholic acid

PROLASTIN C alpha-1-proteinase inhibitor (human, Alpha1-PI)

DUAVIVE conjugated estrogens / bazedoxifene

Antineoplastic and haematological agents

LYNPARZA olaparib

OPDIVO nivolumab

LENVIMA lenvatinib

FARYDAK panobinostat (as lactate)

ZYKADIA ceritinib

KOVALTRY octocog alfa (bhk)

COTELLIC cobimetinib as fumarate

OBIZUR susoctocog alfa (bhk)

TAGRISSO hexaminolevulinate (as hydrochloride)

IDELVION albutrepenonacog alfa

EMPLICITI elotuzumab

NINLARO ixazomib (as citrate)

KYPROLIS carfilzomib

ONIVYDE nanoliposomal irinotecan (as sucrosofate)

Cardiovascular, antidotes and endocrine agents

STRENSIQ asfotase alfa (rch)

NUCALA mepolizumab

ENTRESTO sacubitril / valsartan

UPTRAVI selexipag

SPEDRA avanafil

PRAXBIND idarucizumab (rch)

PRALUENT alirocumab (rch)

ZURAMPIC lesinurad

ANTIZOL fomepizole

Neurological, disease-modifying, fluid/electrolyte and gastro-intestinal agents

MOVANTIK naloxegol (as oxalate)

ADDAVEN chromic chloride hexahydrate, cupric chloride dehydrate, ferric chloride hexahydrate, manganese chloride tetrahydrate, potassium iodide, sodium fluoride, sodium molybdate dihydrate, sodium selenite and zinc chloride

BRIVIACT brivaracetam

TALTZ ixekizumab

ZINBRYTA daclizumab

BELSOMRA suvorexant

Anti-infectives, vaccines and other agents

GENVOYA tenofovir alafenamide (as fumarate) / elvitegravir / cobicistat / emtricitabine

HYQVIA normal immunoglobulin (human) / vorhyaluronidase alfa

AFLURIA QUAD tenofovir alafenamide (as fumarate) / elvitegravir / cobicistat / emtricitabine

ACARIZAX dermatophagoides pteronyssinus and dermatophagoides farina (American house dust mite extract, European house dust mite extract)

HEXVIX hexaminolevulinate (as hydrochloride)

ZEPATIER elbasvir / grazoprevir

FLUMIST QUADRIVALENT influenza virus A (H1N1) / influenza virus A (H3N2) / influenza virus B (Yamagata lineage) / influenza virus B (Victoria lineage) quadrivalent vaccine (live attenuated)

EPCLUSA sofosbuvir / velpatasvir

New registrations 2016 chronological summary

Note that all products were approved within the statutory 255 working day period (which equates to 12 calendar months). The overall approval periods for some products exceeded 12 calendar months for a range of reasons, including extended periods for sponsor responses for information or appeals of an initial decision by TGA (followed by provision of further information by the sponsor).

Australian Public Assessment Reports (AusPARs) 2016 chronological summary

Each AusPAR outlines the outcome of TGA's pre-market registration process for prescription medicines and provides a record of the scientific reasoning and risk-benefit considerations behind the regulatory decision. AusPARs have been published by TGA on our website since November 2009.

Trade name Active ingredient Sponsor Decision AusPAR date Therapeutic use
Cervarix human papillomavirus vaccine types 16 and 18 (recombinant AS04 adjuvanted) GlaxoSmithKline Australia Pty Ltd Approved 4 January 2016 Cervical lesions & cervical cancer
Pradaxa dabigatran etexilate Boehringer Ingelheim Pty Ltd Approved 4 January 2016 Deep vein thrombosis & pulmonary embolism
Valcyte valganciclovir Roche Products Pty Ltd Approved 5 January 2016 Cytomegalovirus (CMV) retinitis
Cortiment budesonide Ferring Pharmaceuticals Pty Ltd Approved 11 January 2016 Ulcerative colitis
Zerbaxa ceftolozane (as sulfate) / azobactam (as sodium salt) Merck Sharp & Dohme Australia Pty Ltd Approved 27 January 2016 Intra-abdominal & urinary tract infections
Trade name Active ingredient Sponsor Decision AusPAR date Therapeutic use
Imbruvica ibrutinib Janssen-Cilag Pty Ltd Approved 2 February 2016 Leukaemia & lymphoma
Revlimid lenalidomide Celgene Pty Ltd Approved 5 February 2016 Multiple myeloma
Ofev /Vargatef nintedanib esilate Boehringer Ingelheim Pty Ltd Approved 8 February 2016 Lung cancer & idiopathic pulmonary fibrosis (IPF)
Zevtera ceftobiprole medocaril sodium JACE Pharma Pty Ltd Approved 8 February 2016 Pneumonia
Lonquex lipegfilgrastim (rbe) Teva Pharma Australia Pty Ltd Approved 23 February 2016 Neutropenia
Velcade bortezomib Janssen-Cilag Pty Ltd Approved 26 February 2016 Mantle cell lymphoma
Trade name Active ingredient Sponsor Decision AusPAR date Therapeutic use
Saxenda liraglutide Novo Nordisk Pharmaceuticals Pty Ltd Approved 23 March 2016 Weight management
Xtandi enzalutamide Astellas Pharma Australia Pty Ltd Approved 23 March 2016 Prostate cancer
Revolade eltrombopag Novartis Australia Pty Ltd Pharmaceuticals Approved 30 March 2016 Severe aplastic anaemia
Trade name Active ingredient Sponsor Decision AusPAR date Therapeutic use
Afoila/ Bemfola follitropin alfa (rch) Finox Biotech Australia Pty Ltd Approved 8 April 2016 Infertility
Trade name Active ingredient Sponsor Decision AusPAR date Therapeutic use
Repatha evolocumab (rch) Amgen Australia Pty Ltd Approved 3 May 2016 Cardiovascular disease
Nuvigil armodafinil Teva Pharmaceuticals Australia Pty Ltd Approved 26 May 2016 Narcolepsy
Imlygic talimogene laherparepvec Amgen Australia Pty Ltd Approved 31 May 2016 Melanoma
Trade name Active ingredient Sponsor Decision AusPAR date Therapeutic use
Movantik naloxegol oxalate AstraZeneca Pty Ltd Approved 1 June 2016 Opioid-induced constipation
Nuwiq simoctocog alfa rhu Octapharma Australia Pty Ltd Approved 7 June 2016 Haemophilia A
Proshaeos alprostadil Commercial Eyes Pty Ltd Withdrawn 9 June 2016 N/A*
Perjeta pertuzumab Roche Products Pty Limited Approved 16 June 2016 Breast cancer
Xolair omalizumab (rch) Novartis Australia Pty Ltd Approved 22 June 2016 Asthma
Genvoya cobicistat / emtricitabine / tenofovir (as fumarate) / elvitegravir alafenamide Gilead Sciences Pty Ltd Approved 28 June 2016 Human Immunodeficiency Virus (HIV)

*Already approved for use in erectile dysfunction

Trade name Active ingredient Sponsor Decision AusPAR date Therapeutic use
Strensiq asfotase alfa (rch) Alexion Pharmaceuticals Australia Pty Ltd Approved 1 July 2016 Paediatric hypophosphatasia
Gliclazide GPPL MR 30 gliclazide Generic Partners Pty Ltd Withdrawn 19 July 2016 N/A
Humira adalimumab (rch) AbbVie Pty Ltd Approved 12 July 2016 Hidradenitis suppurativa (acne inversa)
Trade name Active ingredient Sponsor Decision AusPAR date Therapeutic use
Xiaflex collagenase clostridium histolyticum Actelion Pharmaceuticals Australia Pty Ltd Approved 2 August 2016 Peyronie's disease
Esbriet pirfenidone Roche Products Pty Ltd Approved 9 August 2016 Idiopathic pulmonary fibrosis (IPF)
Selincro nalmefene (as hydrochloride dihydrate) Lundbeck Australia Pty Ltd Approved 9 August 2016 Alcohol use disorder
Opdivo nivolumab Bristol-Myers Squibb Australia Pty Ltd Approved 23 August 2016 Melanoma & lung cancer
Lenvima lenvatinib mesilate Eisai Australia Pty Ltd Approved 30 August 2016 Thyroid cancer
Trade name Active ingredient Sponsor Decision AusPAR date Therapeutic use
Orkambi 200/125 ivacaftor/ lumacaftor Vertex Pharmaceuticals Australia Pty Ltd Approved 8 September 2016 Paediatric cystic fibrosis
Zurampic lesinurad AstraZeneca Pty Ltd Approved 20 September 2016 Hyperuricaemia & gout
Entresto/ Novartis
Sacubitril / Valsartan
sacubitril / valsartan salt complex Novartis Pharmaceuticals Australia Pty Ltd Approved 23 September 2016 Chronic heart failure
Actemra tocilizumab (rch) Roche Products Pty Ltd Approved 29 September 2016 Rheumatoid arthritis
Trade name Active ingredient Sponsor Decision AusPAR date Therapeutic use
Keytruda pembrolizumab (rch) Merck Sharp & Dohme (Australia) Pty Ltd Approved 14 October 2016 Melanoma
Esmya ulipristal acetate Vifor Pharma Pty Ltd Approved 19 October 2016 Uterine fibroids
Cosentyx/ Zafrez secukinumab Novartis Pharmaceuticals Australia Pty Ltd Approved 25 October 2016 Psoriatic arthritis & ankylosing spondylitis
Ozurdex dexamethasone Allergan Australia Pty Ltd Approved 25 October 2016 Diabetic macular oedema (DME)
Praxbind idarucizumab Boehringer Ingelheim Pty Ltd Approved 25 October 2016 Bleeding
Spedra avanafil A Menarini Australia Pty Ltd Approved 27 October 2016 Erectile dysfunction
Akynzeo netupitant / palonosetron (as hydrochloride) Specialised Therapeutics Australia Pty Ltd Approved 28 October 2016 Nausea & vomiting associated with cancer chemotherapy
Trade name Active ingredient Sponsor Decision AusPAR date Therapeutic use
Uptravi selexipag Actelion Pharmaceuticals Pty Ltd Approved 8 November 2016 Pulmonary arterial hypertension
Truvada emtricitabine / tenofovir disoproxil fumarate Gilead Sciences Pty Ltd Approved 10 November 2016 Human Immuno-deficiency Virus (HIV)
Spiriva Respimat/ Favint Respimat tiotropium bromide Boehriger Ingelheim Pty Limited Approved 25 November 2016 Bronchodilator treatment
Trade name Active ingredient Sponsor Decision AusPAR date Therapeutic use
Seasonique levonorgestrel / ethinyloestradiol Teva Pharma Australia Pty Ltd Approved 9 December 2016 Oral contraceptive
Transtec buprenorphine Mundipharma Pty Ltd Rejected 13 December 2016 N/A*
Praluent (Golyra/ Eliriduc) alirocumab (rch) Sanofi-Aventis Australia Pty Ltd Approved 13 December 2016 Cholesterol management
Descovy emtricitabine / tenofovir alafenamide (as fumarate) Gilead Sciences Pty Ltd Approved 20 December 2016 Human Immuno-deficiency Virus (HIV)

*Already approved for use in the treatment of pain and opiate dependence.


ISSN: 2204-9843 (print)

ISSN: 2207-6840 (online)