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

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.

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.

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.

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).

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.

BLINCYTO

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).

ILEVRO

nepafenac

Sponsor: Alcon Laboratories Australia Pty Ltd

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

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.

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).

SYLVANT

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.

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.

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.

CYRAMZA

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.

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.

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.

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).

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).

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.

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).

HARVONI

ledipasvir/ sofosbuvir

Sponsor: Gilead Sciences Pty Ltd

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

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.

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.

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.

KEYTRUDA

pembrolizumab

Sponsor: Merck Sharp & Dohme (Australia) Pty Ltd

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

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.

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.

ELLAONE

ulipristal acetate

Sponsor: ERA Consulting (Australia) Pty Ltd

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

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).

FOLOTYN

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.

CERDELGA

eliglustat (as tartrate)

Sponsor: Sanofi-Aventis Australia Pty Ltd

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

CARBAGLU

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.

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.

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.

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.

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.