Prescription medicines: registration of new chemical entities in Australia, 2016

31 January 2017

2016 summary

cover of annual summary

The Prescription medicines and biologicals: annual summary 2016 publication provides details of all NCEs registered in 2016 in addition to some information on new or extended uses for existing medicines. This year's summary also provides details of TGA's Australian Public Assessment Reports (AusPARs) and regulatory framework for biologicals.

In recent years, approximately 40 new prescription medicines containing new active substances are registered by the TGA.

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The trade name, sponsor and active ingredient for each medicine reflects the information initially entered in the Australian Register of Therapeutic Goods (ARTG) (i.e. date registered).

For further information on the full wording of each indication please refer to the product's individual 'Public ARTG Summary': Search the ARTG

This list contains links to published Australian Public Assessment Reports (AusPAR). The AusPAR provides more information about the evaluation of the medicine and the considerations that led the TGA to register it.

Registration of NCEs

Orphan drug orphan drug

2016: Dec Nov Oct Sep Aug Jul Jun May Apr Mar Feb Jan

December 2016

New prescription medicines containing new active substances in December 2016
Medicine Date registered

ANTIZOL orphan drug

fomepizole

Sponsor: AFT Pharmaceuticals Pty Limited

For the treatment of ethylene glycol or methanol poisoning.

1 December 2016

KYPROLIS

carfilzomib

Sponsor: Amgen Australia Pty Ltd

For use in combination with dexamethasone or lenalidomide and dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

19 December 2016

EPCLUSA

sofosbuvir / velpatasvir

Sponsor: Gilead Sciences Pty Ltd

For the treatment of chronic hepatitis C virus (HCV) infection (genotype 1, 2, 3, 4, 5 or 6) in adults.

19 December 2016

ONIVYDE

nanoliposomal irinotecan (as sucrosofate)

Sponsor: Baxalta Australia Pty Ltd

For the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil and folinic acid (leucovorin) in adult patients who have been previously treated with gemcitabine-based therapy.

19 December 2016

November 2016

New prescription medicines containing new active substances in November 2016
Medicine Date registered

BELSOMRA

suvorexant

Sponsor: Merck Sharp & Dohme Australia Pty Ltd

For the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. Following initiation of treatment, continuation should be re-evaluated after 3 months.

16 November 2016

NINLARO

ixazomib (as citrate)

Sponsor: Takeda Pharmaceuticals Australia Pty Ltd

For use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

15 November 2016

PROLASTIN C

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

Sponsor: Grifols Australia Pty Ltd

Used to increase serum Alpha1-PI levels in adults with congenital deficiency of alpha-1 antitrypsin and with clinically significant emphysema (FEV1 <80%).

10 November 2016

October 2016

New prescription medicines containing new active substances in October 2016
Medicine Date registered

FLUMIST QUADRIVALENT

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

Sponsor: AstraZeneca Pty Ltd

For the prevention of influenza in children and adolescents from 24 months to less than 18 years of age.

18 October 2016

September 2016

New prescription medicines containing new active substances in September 2016
Medicine Date registered

EMPLICITI

elotuzumab

Sponsor: Bristol-Myers Squibb Australia Pty Ltd

For use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

22 September 2016

ZINBRYTA

daclizumab

Sponsor: Biogen Australia Pty Ltd

For the treatment of relapsing forms of multiple sclerosis (MS) to delay the progression of physical disability and to reduce the frequency of relapse.

22 September 2016

IDELVION orphan drug

albutrepenonacog alfa

Sponsor: CSL Behring Australia Pty Ltd

For use in all patients with haemophilia B for:

  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes;
  • Control and prevention of bleeding episodes;
  • Control and prevention of bleeding in the perioperative setting
20 September 2016

TALTZ

ixekizumab

Sponsor: Eli Lilly Australia Pty Ltd

For the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

6 September 2016

August 2016

New prescription medicines containing new active substances in August 2016
Medicine Date registered

ZEPATIER

elbasvir / grazoprevir

Sponsor: Merck Sharp & Dohme (Australia) Pty Ltd

For the treatment of Chronic Hepatitis C genotype 1 or 4 infection in adults.

29 August 2016

HEXVIX

hexaminolevulinate (as hydrochloride)

Sponsor: Juno Pharmaceuticals Pty Ltd

For diagnostic use only, Hexvix blue light fluorescence cystoscopy is indicated as adjunct to standard white light cystoscopy to contribute to the diagnosis and management of bladder cancer in patients with known or high suspicion of bladder cancer.

16 August 2016

BRIVIACT

brivaracetam

Sponsor: UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

For use as add-on therapy in the treatment of partial-onset seizures with or without secondary generalisation in patients from 16 years of age with epilepsy.

4 August 2016

TAGRISSO

osimertinib mesilate

Sponsor: AstraZeneca Pty Ltd

For the treatment of patients with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer based on tumour response rate and duration of response.

3 August 2016

ACARIZAX

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

Sponsor: Seqirus Pty Ltd

For the treatment of adults diagnosed with house dust mite (HDM) allergic rhinitis not well controlled despite use of symptom relieving medication or HDM allergic asthma not well controlled by inhaled corticosteroids and associated with HDM allergic rhinitis.

1 August 2016

July 2016

New prescription medicines containing new active substances in July 2016
Medicine Date registered

ADDAVEN

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

Sponsor: Fresenius Kabi Australia Pty Limited

For use to meet basal to moderately increased requirements of trace elements in parenteral nutrition in adults, when either oral or enteral nutrition is inappropriate.

29 July 2016

AFLURIA QUAD

inactivated quadrivalent influenza vaccine (split virion)

Sponsor: CSL Limited

For use in persons aged 18 years and over for the prevention of influenza caused by Influenza Virus. Types A and B contained in the vaccine.

22 July 2016

BELKYRA

deoxycholic acid

Sponsor: Allergan Australia Pty Ltd

To be used for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.

21 July 2016

June 2016

New prescription medicines containing new active substances in June 2016
Medicine Date registered

ZURAMPIC

lesinurad

Sponsor: AstraZeneca Pty Ltd

For use in combination with a xanthine oxidase inhibitor for the treatment of hyperuricaemia associated with gout in patients who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.

1 June 2016

May 2016

New prescription medicines containing new active substances in May 2016
Medicine Date registered

PRALUENT

alirocumab (rch)

Sponsor: Sanofi-Aventis Australia Pty Ltd

For use as an adjunct to diet and exercise in adults with heterozygous familial hypercholesterolaemia or clinical atherosclerotic cardiovascular disease:

  • in combination with a statin, or statin with other lipid-lowering therapies or;
  • in combination with other lipid-lowering therapies in patients who are statin-intolerant.
17 May 2016

PRAXBIND

idarucizumab (rch)

Sponsor: Boehringer lngelheim Pty Ltd

For use as a specific reversal agent in patients treated with dabigatran etexilate (PRADAXA) when rapid reversal of the anticoagulant effects is required for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding.

11 May 2016

April 2016

New prescription medicines containing new active substances in April 2016
Medicine Date registered

OBIZUR orphan drug

susoctocog alfa (bhk)

Sponsor: Baxalta Australia Pty Ltd

For the treatment of bleeding episodes in adults with acquired haemophilia A.

29 April 2016

HYQVIA

normal immunoglobulin (human) / vorhyaluronidase alfa

Sponsor: Baxalta Australia Pty Ltd

For replacement therapy in adults in:

  • Primary Immunodeficiency Disease (PID) and
  • Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.
27 April 2016

SPEDRA

avanafil

Sponsor: A Menarini Australia Pty Ltd

For the treatment of erectile dysfunction in adult males.

6 April 2016

COTELLIC

cobimetinib (as fumarate)

Sponsor: Roche Products Pty Ltd

For use in combination with ZELBORAF (vemurafenib) for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation.

5 April 2016

KOVALTRY

octocog alfa (bhk)

Sponsor: Bayer Australia Ltd

For the treatment and prophylaxis of bleeding in patients of all ages with haemophilia A (congenital factor VIII deficiency).

1 April 2016

March 2016

New prescription medicines containing new active substances in March 2016
Medicine Date registered

ZYKADIA orphan drug

ceritinib

Sponsor: Novartis Pharmaceuticals Australia Pty Ltd

As monotherapy for the treatment of adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on or who are intolerant of crizotinib.

31 March 2016

FARYDAK

panobinostat (as lactate)

Sponsor: Novartis Pharmaceuticals Australia Pty Ltd

In combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.

31 March 2016

UPTRAVI orphan drug

selexipag

Sponsor: Actelion Pharmaceuticals Australia Pty Ltd

For the treatment of:

  • idiopathic pulmonary arterial hypertension;
  • heritable pulmonary arterial hypertension;
  • pulmonary arterial hypertension associated with connective tissue disease;
  • pulmonary arterial hypertension associated with congenital heart disease with repaired shunts;
  • pulmonary arterial hypertension associated with drugs and toxins; in patients with WHO functional
  • class II, III or IV symptoms.
24 March 2016

ORKAMBI orphan drug

lumacaftor/ivacaftor

Sponsor: Vertex Pharmaceuticals Australia Pty Ltd

For the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the CFTR gene.

8 March 2016

February 2016

New prescription medicines containing new active substances in February 2016
Medicine Date registered

ESBRIET

pirfenidone

Sponsor: Roche Products Pty Ltd

For the treatment of idiopathic pulmonary fibrosis (IPF).

29 Feb 2016

NUCALA

mepolizumab

Sponsor: GlaxoSmithKline Australia Pty Ltd

As an add-on treatment for severe refractory eosinophilic asthma in patients aged 12 years and over.

2 Feb 2016

January 2016

New prescription medicines containing new active substances in January 2016
Medicine Date registered

LENVIMA orphan drug

lenvatinib

Sponsor: Eisai Australia Pty Ltd

For the treatment of patients with progressive, locally advanced or metastatic, radioactive iodine refractory differentiated thyroid cancer.

28 Jan 2016

ENTRESTO

sacubitril/valsartan (combined as a sodium salt hydrate complex)

Sponsor: Novartis Pharmaceuticals Australia Pty Limited

For the treatment of chronic heart failure (NYHA Class II-IV) with reduced ejection fraction in adult patients.

20 Jan 2016

GENVOYA

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

Sponsor: Gilead Sciences Pty Ltd

A single tablet regimen for the treatment of HIV-1 infection in adults and adolescents aged 12 years of age and older with body weight at least 35 kg who are either treatment–naïve; or virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen.

15 Jan 2016

STRENSIQ orphan drug

asfotase alfa rch

Sponsor: Alexion Pharmaceuticals Australasia Pty Ltd

For enzyme replacement therapy in patients with paediatric-onset hypophosphatasia.

14 Jan 2016

OPDIVO

nivolumab

Sponsor: Bristol-Myers Squibb Australia Pty Ltd

As monotherapy for the treatment of patients with unresectable (Stage III) or metastatic (Stage IV) melanoma, or locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy.

In combination with YERVOY (ipilimumab) for the treatment of patients with metastatic (Stage IV) melanoma with M1c disease or elevated lactic dehydrogenase (LDH).

11 Jan 2016

MOVANTIK

naloxegol (as oxalate)

Sponsor: AstraZeneca Pty Ltd

For the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).

7 Jan 2016

LYNPARZA orphan drug

olaparib

Sponsor: AstraZeneca Pty Ltd

As monotherapy for the maintenance treatment of patients with platinum-sensitive relapsed BRCA-mutated (germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) after platinum-based chemotherapy.

7 Jan 2016