Prescription medicines: registration of new chemical entities in Australia, 2015

2 June 2016

2015 summary

The Prescription medicines: annual summary 2015 publication provides details of all NCEs registered in 2015 in addition to some information on new or extended uses for existing medicines.

Each year, approximately 40 new prescription medicines containing new active substances are registered. These are called New Chemical Entities (NCEs) 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

2015: Dec Nov Oct Sep Aug Jul Jun May Apr Mar Feb Jan

Previous years: 2014

December 2015

New prescription medicines containing new active substances in December 2015
Medicine Date registered

IMLYGIC

talimogene laherparepvec

Sponsor: Amgen Australia Pty Ltd

As monotherapy for the treatment of melanoma in patients with unresectable cutaneous, subcutaneous or nodal lesions after initial surgery.

21 Dec 2015

REPATHA

evolocumab (rch)

Sponsor: Amgen Australia Pty Ltd

As an adjunct to diet and exercise in:

  • adults with heterozygous familial hypercholesterolaemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD);
    • 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
  • adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.
9 Dec 2015

November 2015

New prescription medicines containing new active substances in November 2015
Medicine Date registered

NUVIGIL

armodafinil

Sponsor: Teva Pharma Australia Pty Ltd

To improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.

To treat excessive sleepiness associated with moderate to severe chronic shift work sleep disorder where non-pharmacological interventions are unsuccessful or inappropriate.

As an adjunct to continuous positive airways pressure (CPAP) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness.

26 Nov 2015

LONQUEX

lipegfilgrastim (rbe)

Sponsor: Teva Pharma Australia Pty Ltd

For the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

12 Nov 2015

ZEVTERA

ceftobiprole medocaril sodium

Sponsor: JACE Pharma Pty Ltd

For the treatment of:

  • Hospital-acquired pneumonia (HAP), excluding ventilator-associated pneumonia (VAP)
  • Community-acquired pneumonia (CAP)

in adults suspected or proven to be caused by designated susceptible microorganisms.

10 Nov 2015

BLINCYTO orphan drug

blinatumomab (rch)

Sponsor: Amgen Australia Pty Ltd

For the treatment of adults with Philadelphia chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).

9 Nov 2015

ILEVRO

nepafenac

Sponsor: Alcon Laboratories Australia Pty Ltd

For the prevention and treatment of postoperative pain and inflammation associated with cataract surgery.

4 Nov 2015

ZERBAXA

ceftolozane sulfate/tazobactam sodium

Sponsor: Merck Sharp & Dohme Australia Pty Ltd

For the treatment of:

  • complicated intra-abdominal infections in combination with metronidazole
  • complicated urinary tract infections, including pyelonephritis

in adults suspected or proven to be caused by designated susceptible microorganisms.

4 Nov 2015

October 2015

For the month of October there are no new entries.

September 2015

New prescription medicines containing new active substances in September 2015
Medicine Date registered

OFEV

nintedanib (as esilate)

Sponsor: Boehringer Ingelheim Pty Ltd

In combination with docetaxel for the treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after failure of first line chemotherapy.

For the treatment of Idiopathic Pulmonary Fibrosis (IPF).

1 Sep 2015

August 2015

New prescription medicines containing new active substances in August 2015
Medicine Date registered

SYLVANT orphan drug

siltuximab (rmc)

Sponsor: Janssen-Cilag Pty Ltd

For the treatment of patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.

31 Aug 2015

ODOMZO

sonidegib diphosphate

Sponsor: Novartis Pharmaceuticals Australia Pty Ltd

For the treatment of adult patients with:

locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy metastatic BCC.

10 Aug 2015

July 2015

New prescription medicines containing new active substances in July 2015
Medicine Date registered

ALBUNATE

human albumin

Sponsor: CSL Ltd

For the restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.

30 Jul 2015

CYRAMZA orphan drug

ramucirumab

Sponsor: Eli Lilly Pty Ltd

In combination with paclitaxel, for the treatment of adult patients with advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma with disease progression after prior platinum and fluropyrimidine chemotherapy.

As monotherapy, for the treatment of adult patients with advanced or metastatic gastric or gastro oesophageal junction adenocarcinoma with disease progression after prior platinum or fluoropyrimidine chemotherapy when treatment in combination with paclitaxel is not appropriate.

23 Jul 2015

VIEKIRA PAK-RVB

paritaprevir/ritonavir/ombitasvir tablets
dasabuvir (as sodium salt) tablets
ribavirin tablets

Sponsor: Abbvie Pty Ltd

For the treatment of genotype 1 chronic hepatitis C infection, including patients with compensated cirrhosis.

21 Jul 2015

VIEKIRA PAK

paritaprevir/ritonavir/ombitasvir tablets
dasabuvir (as sodium salt) tablets

Sponsor: Abbvie Pty Ltd

For the treatment of genotype 1 chronic hepatitis C infection, including patients with compensated cirrhosis.

10 Jul 2015

June 2015

New prescription medicines containing new active substances in June 2015
Medicine Date registered

GARDASIL 9

human papillomavirus 9-valent vaccine

Sponsor: Merck Sharp & Dohme (Australia) Pty Limited

For use in females aged 9 through 45 years for the prevention of cervical, vulvar, vaginal and anal cancer, precancerous or dysplastic lesions, genital warts, and infection caused by Human Papillomavirus (HPV) Types 6,11,16,18,31,33,45,52 and 58 (which are included in the vaccine).

For use in males 9 through 26 years of age for the prevention of anal cancer, precancerous or dysplastic lesions, external genital lesions and infection caused by HPV types 6,11,16,18,31,33,45,52 and 58 (which are included in the vaccine).

29 Jun 2015

DAKLINZA

daclatasvir (as dihydrochloride)

Sponsor: Bristol-Myers Squibb Australia Pty Ltd

In combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults with compensated liver disease (including cirrhosis).

25 Jun 2015

SELINCRO

nalmefene (as hydrochloride dihydrate)

Sponsor: Lundbeck Australia Pty Ltd

For the reduction of alcohol consumption in adult patients with alcohol use disorder who have an average daily consumption of alcohol of more than 60 g for men and more than 40 g for women.

17 Jun 2015

May 2015

New prescription medicines containing new active substances in May 2015
Medicine Date registered

SUNVEPRA

asunaprevir

Sponsor: Bristol-Myers Squibb Australia Pty Ltd

In combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults with compensated liver disease (including cirrhosis).

25 May 2015

HARVONI

ledipasvir/ sofosbuvir

Sponsor: Gilead Sciences Pty Ltd

For the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults.

13 May 2015

AKYNZEO

netupitant/ palonosetron (as hydrochloride)

Sponsor: Specialised Therapeutics Australia Pty Ltd

In adult patients for prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately or highly emetogenic cancer chemotherapy.

6 May 2015

April 2015

New prescription medicines containing new active substances in April 2015
Medicine Date registered

IMBRUVICA

ibrutinib

Sponsor: Janssen-Cilag Pty Ltd

For the treatment of:

patients with chronic lymphocytic leukaemia (CLL)/ small lymphocytic lymphoma (SLL) who have received at least one prior therapy (or as first line in patients with CLL with 17p deletion)

patients with mantle cell lymphoma who have received at least one prior therapy.

20 Apr 2015

RENVELA

sevelamer carbonate

Sponsor: Sanofi-Aventis Australia Pty Ltd

For the management of hyperphosphataemia in adult patients with stage 4 and 5 chronic kidney disease.

20 Apr 2015

KEYTRUDA

pembrolizumab

Sponsor: Merck Sharp & Dohme (Australia) Pty Ltd

As monotherapy for the treatment of unresectable or metastatic melanoma in adults.

16 Apr 2015

March 2015

New prescription medicines containing new active substances in March 2015
Medicine Date registered

OTEZLA

apremilast

Sponsor: Celgene Pty Limited

For the treatment of:

signs and symptoms of active psoriatic arthritis in adult patients

adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

19 Mar 2015

OPTAFLU

inactivated influenza virus vaccine

Sponsor: Novartis Influenza Vaccines Pty Ltd

For the prevention of influenza caused by Influenza Virus Types A and B in adults over 18 years of age.

13 Mar 2015

ELLAONE

ulipristal acetate

Sponsor: ERA Consulting (Australia) Pty Ltd

For emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

6 Mar 2015

DECAPEPTYL

triptorelin acetate

Sponsor: Ferring Pharmaceuticals Pty Ltd

For down-regulation and prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART).

4 Mar 2015

February 2015

New prescription medicines containing new active substances in February 2015
Medicine Date registered

FOLOTYN orphan drug

pralatrexate

Sponsor: Mundipharma Pty Ltd

For the treatment of adult patients with peripheral T-cell lymphoma (nodal, extra nodal and leukaemic /disseminated) who have progressed after at least one prior therapy.

26 Feb 2015

CERDELGA orphan drug

eliglustat (as tartrate)

Sponsor: Sanofi-Aventis Australia Pty Ltd

For the long-term treatment of adults with Gaucher disease type 1 (GD1).

17 Feb 2015

CARBAGLU orphan drug

carglumic acid

Sponsor: Emerge Health Pty Ltd

For the treatment of hyperammonemia due to N-acetylglutamate synthase primary deficiency and hyperammonemia due to organic acidaemias.

12 Feb 2015

ZYDELIG

idelalisib

Sponsor: Gilead Sciences Pty Ltd

For the treatment of patients with refractory follicular lymphoma, who have received at least 2 prior systemic therapies.

In combination with rituximab, for the treatment of patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL) for whom chemo-immunotherapy is not considered suitable, either:

upon relapse after at least one prior therapy; or

as first-line treatment in the presence of 17p deletion or TP53 mutation.

9 Feb 2015

XELJANZ

tofacitinib (as citrate)

Sponsor: Pfizer Australia Pty Ltd

For the treatment of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to previous disease-modifying antirheumatic drug (DMARD) therapy. Can be used alone or in combination with DMARDS, including methotrexate.

For the treatment of the signs and symptoms of moderate to severe active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to methotrexate. Can be used alone on in combination with nonbiological DMARDs, including methotrexate.

5 Feb 2015

January 2015

New prescription medicines containing new active substances in January 2015
Medicine Date registered

TRULICITY

dulaglutide (rch)

Sponsor: Eli Lilly Australia Pty Ltd

In addition to diet and exercise, to improve glycaemic control in adults with type 2 diabetes mellitus:

  • as monotherapy orin combination with oral glucose-lowering medications orin combination with prandial insulin, with or without metformin.
19 Jan 2015

COSENTYX / ZAFREZ

secukinumab (rch)

Sponsor: Novartis Pharmaceuticals Australia Pty Ltd

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

12 Jan 2015