Prescription medicines: registration of new chemical entities in Australia

12 December 2017

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

Some of these NCEs are innovative or 'first-in-class', and have been made available for the first time outside the controlled environment of a clinical trial.

This decision by the TGA often comes after years of research and development and following a comprehensive review by the TGA scientists and clinicians of the quality, safety and efficacy of the new prescription medicines.

Throughout the year we will be publishing information on the new prescription medicines when they are approved. However, it may still be some time before the pharmaceutical company decides to supply the product in Australia.

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

Registration of NCEs

Orphan drug orphan drug

2017: Dec Nov Oct Sep Aug Jul May Apr Mar Feb Jan

Previous years: 2016 2015 2014

December 2017

New prescription medicines containing new active substances in December 2017
Medicine Date registered

MONOFER

ferric derisomaltose

Sponsor: Link Medical Products Pty Ltd

Monofer is indicated for the treatment of iron deficiency in adults, under the following conditions:

  • When oral iron preparations are ineffective or cannot be used;
  • Where there is a clinical need to deliver iron rapidly.

The diagnosis must be based on laboratory tests.

04 December 2017

November 2017

New prescription medicines containing new active substances in November 2017
Medicine Date registered

TRESIBA FLEXTOUCH and TRESIBA PENFILL

insulin degludec (rys)

Sponsor: Novo Nordisk Pharmaceuticals Pty Ltd

Tresiba Flextouch and Tresiba Penfill are indicated to improve glycaemic control in adult patients with diabetes mellitus requiring insulin.

29 November 2017

RYZODEG 70/30 FLEXTOUCH and RYZODEG 70/30 PENFILL

70% insulin degludec (rys) / 30% insulin aspart (rys)

Sponsor: Novo Nordisk Pharmaceuticals Pty Ltd

Ryzodeg 70/30 Flextouch and Ryzodeg 70/30 Penfill are indicated to improve glycaemic control in adult patients with diabetes mellitus requiring basal and prandial insulin.

29 November 2017

ZINPLAVA

bezlotoxumab (rch)

Sponsor: Merck Sharp & Dohme Australia Pty Ltd

Zinplava is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adult patients 18 years or older at high risk for recurrence of CDI who are receiving antibiotic therapy for CDI. Zinplava should only be used in conjunction with antibacterial drug treatment of CDI.

13 November 2017

SPINRAZA orphan drug

nusinersen (as heptadecasodium)

Sponsor: Biogen Australia Pty Ltd

Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy (SMA).

3 November 2017

INFLUVAC TETRA

influenza virus haemagglutinin vaccine

Sponsor: Mylan Health Pty Ltd

Influvac Tetra is indicated for the prevention of influenza caused by influenza virus, types A and B, in adults (18 years of age and older).

2 November 2017

October 2017

New prescription medicines containing new active substances in October 2017
Medicine Date registered

ONCASPAR orphan drug

pegaspargase

Sponsor: Baxalta Australia Pty Ltd

Oncaspar is indicated as a component of antineoplastic combination therapy in patients with Acute Lymphoblastic Leukaemia (ALL).

31 October 2017

KISQALI

ribociclib (as succinate)

Sponsor: Novartis Pharmaceuticals Australia Pty Ltd

Kisqali, in combination with an aromatase inhibitor, is indicated for the treatment of men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer, as an initial endocrine-based therapy.

23 October 2017

RANEXA

ranolazine

Sponsor: A. Menarini Australia Pty Ltd

Ranexa is indicated in adults as add-on therapy for the symptomatic treatment of stable angina pectoris in patients taking maximum tolerated doses of a beta-blocker or a calcium channel blocker and have inadequate symptom control.

13 October 2017

September 2017

New prescription medicines containing new active substances in September 2017
Medicine Date registered

TRUMENBA

meningococcal group B vaccine

Sponsor: Pfizer Australia Pty Ltd

Trumenba is indicated in individuals 10 years and older for active immunisation to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

14 September 2017

MONUROL

fosfomycin trometamol

Sponsor: Mayne Pharma International Pty Ltd

Monurol is indicated only for the treatment of acute uncomplicated lower urinary tract infections (acute cystitis) in females above 12 years of age caused by the following susceptible pathogens: Enterobacteriaceae (including Escherichia coli), Enterococcus faecalis.

4 September 2017

August 2017

New prescription medicines containing new active substances in August 2017
Medicine Date registered

INTUNIV

guanfacine (as hydrochloride)

Sponsor: Shire Australia Pty Ltd

Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6-17 years old, as monotherapy (when stimulants or atomoxetine are not suitable, not tolerated or have been shown to be ineffective) or as adjunctive therapy to psychostimulants (where there has been a sub-optimal response to psychostimulants). Intuniv must be used as part of a comprehensive ADHD management programme, typically including psychological, educational and social measures.

22 August 2017

GALAFOLD orphan drug

migalastat (as hydrochloride)

Sponsor: ERA Consulting (Australia) Pty Ltd

Galafold is indicated for long-term treatment of adult and adolescent patients 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation.

11 August 2017

July 2017

New prescription medicines containing new active substances in July 2017
Medicine Date registered

TECENTRIQ

atezolizumab (rch)

Sponsor: Roche Products Pty Ltd

Tecentriq is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy. In patients with tumour EGFR or ALK genomic aberrations, Tecentriq should be used after progression on or after targeted therapy.

27 July 2017

CINQAIR/CINQAERO

reslizumab

Sponsor: Teva Pharma Australia Pty Ltd

Cinqair/Cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma (blood eosinophil count ≥400 cells/μL).

25 July 2017

DENGVAXIA

Dengue tetravalent vaccine-live, attenuated

Sponsor: Sanofi-Aventis Australia Pty Ltd

Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 through 45 years of age living in endemic areas.

20 July 2017

DARZALEX / JANSSEN DARATUMUMAB

daratumumab

Sponsor: Janssen-Cilag Pty Ltd

Darzalex / Janssen Daratumumab is indicated:

  • in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy;
  • as monotherapy, for the treatment of patients with multiple myeloma who have received 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.
17 July 2017

OCREVUS

ocrelizumab

Sponsor: Roche Products Pty Ltd

Ocrevus is indicated for the treatment of patients with:

  • relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and to reduce the frequency of relapse;
  • primary progressive multiple sclerosis (PPMS) to delay the progression of physical disability.
13 July 2017

June 2017

There were no new entries for June.

May 2017

New prescription medicines containing new active substances in May 2017
Medicine Date registered

PHEBURANE

sodium phenylbutyrate

Sponsor: Orpharma Pty Ltd

Pheburane is indicated for the management of hyperammonaemia associated with urea cycle disorders. Pheburane should be used with dietary protein restriction and, in some cases, dietary supplements (e.g. essential amino acids, arginine, citrulline, and protein-free calorie supplements).

30 May 2017

LONSURF/ORCANTAS

trifluridine/tipiracil hydrochloride

Sponsor: Servier Laboratories (Aust) Pty Ltd

Lonsurf/Orcantas is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.

23 May 2017

UROREC

silodosin

Sponsor: Mayne Pharma International Pty Ltd

Urorec is indicated for the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia in adult men.

23 May 2017

REXULTI

brexipiprazole

Sponsor: Lundbeck Australia Pty Limited

Rexulti is indicated in adult patients for the treatment of schizophrenia.

19 May 2017

REVESTIVE orphan drug

teduglutide

Sponsor: Shire Australia Pty Ltd

Revestive is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. Patients should be stable at least to 4 weeks on their parenteral support regimen before initiating teduglutide therapy.

19 May 2017

KANUMA orphan drug

sebelipase alfa rce

Sponsor: Alexion Pharmaceuticals Australasia Pty Ltd

Kanuma is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase deficiency (LAL-D).

18 May 2017

IBRANCE

palbociclib

Sponsor: Pfizer Australia Pty Ltd

Ibrance is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:

  • an aromatase inhibitor as initial endocrine-based therapy
  • fulvestrant in patients who have received prior therapy.
3 May 2017

April 2017

New prescription medicines containing new active substances in April 2017
Medicine Date registered

AFSTYLA orphan drug

lonoctocog alfa (recombinant single-chain coagulation factor VIII)

Sponsor: CSL Behring Australia Pty Ltd

Afstyla is indicated in adult and paediatric patients with haemophilia A (congenital FVIII deficiency) for:

  • Control and prevention of bleeding episodes
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
  • Perioperative management (surgical prophylaxis).

Afstyla is not indicated for the treatment of von Willebrand disease.

13 Apr 2017

March 2017

New prescription medicines containing new active substances in March 2017
Medicine Date registered

REKOVELLE

follitropin delta (rhu)

Sponsor: Ferring Pharmaceuticals Pty Ltd

Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.

31 Mar 2017

ADYNOVATE

rurioctocog alfa pegol (antihaemophilic factor VIII Recombinant Coagulation Factor VIII rch)

Sponsor: Baxalta Australia Pty Ltd

Adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia A (congenital factor VIII deficiency) patients for:

  • Control and prevention of bleeding episodes
  • Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
  • Perioperative management (surgical prophylaxis).

It is not indicated for the treatment of von Willebrand disease.

21 Mar 2017

ALECENSA orphan drug

alectinib

Sponsor: Roche Products Pty Ltd

For the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

14 Mar 2017

GRAZAX

standardised allergen extract of grass pollen from Timothy grass (Phleum pratense)

Sponsor: Seqirus Pty Ltd

For disease modifying treatment of grass pollen (Phleum pratense or allergens cross reacting with P. pratense) induced allergic rhinitis with or without conjunctivitis in adults, adolescents and children above the age of 5 years.

7 Mar 2017

February 2017

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

ZEMAIRA orphan drug

human alpha-1-proteinase inhibitor

Sponsor: CSL Behring Australia Pty Ltd

For maintenance treatment to slow the progression of emphysema in adults with documented severe A1-PI deficiency and progressive lung disease.

13 Feb 2017

January 2017

New prescription medicines containing new active substances in January 2017
Medicine Date registered

VENCLEXTA

venetoclax

Sponsor: Abbvie Pty Ltd

For the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) with 17p deletion, or patients with relapsed or refractory CLL for whom there are no other suitable treatment options.

5 Jan 2017