Prescription medicines: registration of new chemical entities in Australia, 2017

Related information

26 March 2018

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).

2017 summary

cover of report

The Prescription medicines and biologicals: TGA annual summary 2017 publication provides details of all NCEs registered in 2017, as well as new or extended uses for existing medicines, priority determinations and orphan drug designations, biologicals, generic prescription medicines, biosimilar prescription medicines and Australian Public Assessment Reports (AusPARs).

Registration of NCEs, 2017

Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. This timeframe is underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, the time allocated to the sponsor to respond to requests for information, 'mutual clock stop' periods agreed with the sponsor, or other review activities.

All products were approved within the statutory 255 working day period.


symbol denoting an orphan drug

Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market


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

December 2017

FLUZONE HIGH-DOSE

Evaluation commenced: 31 March 2017

Registration decision: 20 December 2017

Entry onto ARTG: 21 December 2017

Approval time: 162 working days

inactivated trivalent influenza vaccine (Split Virion)

Sanofi-Aventis Australia Pty Ltd

Fluzone High-Dose is indicated for active immunisation against influenza disease caused by influenza virus types A and B contained in the vaccine for use in persons 65 years of age and older.

VELTASSA

Evaluation commenced: 31 October 2016

Registration decision: 5 December 2017

Entry onto ARTG: 12 December 2017

Approval time: 231 working days

patiromer sorbitex calcium

Vifor Pharma Pty Ltd

Veltassa is indicated for the treatment of hyperkalaemia in adults.

MONOFER

Evaluation commenced: 1 November 2016

Registration decision: 29 November 2017

Entry onto ARTG: 4 December 2017

Approval time: 234 working days

ferric derisomaltose

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.

November 2017

TRESIBA FLEXTOUCH and TRESIBA PENFILL

Evaluation commenced: 31 October 2016

Registration decision: 23 November 2017

Entry onto ARTG: 29 November 2017

Approval time: 228 working days

insulin degludec (rys)

Novo Nordisk Pharmaceuticals Pty Ltd

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

RYZODEG 70/30 FLEXTOUCH and RYZODEG 70/30 PENFILL

Evaluation commenced: 31 October 2016

Registration decision: 24 November 2017

Entry onto ARTG: 29 November 2017

Approval time: 228 working days

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

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.

ZINPLAVA

Evaluation commenced: 30 November 2016

Registration decision: 8 November 2017

Entry onto ARTG: 13 November 2017

Approval time: 192 working days

bezlotoxumab (rch)

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.

SPINRAZA orphan drug

Evaluation commenced: 4 January 2017

Registration decision: 2 November 2017

Entry onto ARTG: 3 November 2017

Approval time: 167 working days

nusinersen (as heptadecasodium)

Biogen Australia Pty Ltd

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

INFLUVAC TETRA

Evaluation commenced: 30 November 2016

Registration decision: 1 November 2017

Entry onto ARTG: 2 November 2017

Approval time: 189 working days

influenza virus haemagglutinin vaccine

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).

October 2017

ONCASPAR orphan drug

Evaluation commenced: 30 September 2016

Registration decision: 19 October 2017

Entry onto ARTG: 31 October 2017

Approval time: 226 working days

pegaspargase

Baxalta Australia Pty Ltd

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

KISQALI

Evaluation commenced: 31 October 2016

Registration decision: 20 October 2017

Entry onto ARTG: 23 October 2017

Approval time: 231 working days

ribociclib (as succinate)

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.

RANEXA

Evaluation commenced: 29 May 2015

Registration decision: 12 May 2016

Entry onto ARTG: 13 October 2017

Approval time: 197 working days

ranolazine

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.

September 2017

TRUMENBA

Evaluation commenced: 29 July 2016

Registration decision: 12 September 2017

Entry onto ARTG: 14 September 2017

Approval time: 202 working days

meningococcal group B vaccine

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.

MONUROL

Evaluation commenced: 31 August 2016

Registration decision: 31 August 2017

Entry onto ARTG: 4 September 2017

Approval time: 209 working days

fosfomycin trometamol

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.

August 2017

INTUNIV

Evaluation commenced: 31 May 2016

Registration decision: 16 August 2017

Entry onto ARTG: 22 August 2017

Approval time: 233 working days

guanfacine (as hydrochloride)

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.

GALAFOLD orphan drug

Evaluation commenced: 30 June 2016

Registration decision: 9 August 2017

Entry onto ARTG: 11 August 2017

Approval time: 221 working days

migalastat (as hydrochloride)

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.

July 2017

TECENTRIQ

Evaluation commenced: 31 July 2016

Registration decision: 26 July 2017

Entry onto ARTG: 27 July 2017

Approval time: 210 working days

atezolizumab (rch)

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.

CINQAIR/CINQAERO

Evaluation commenced: 29 July 2016

Registration decision: 17 July 2017

Entry onto ARTG: 25 July 2017

Approval time: 201 working days

reslizumab

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).

DENGVAXIA

Evaluation commenced: 30 June 2016

Registration decision: 13 July 2017

Entry onto ARTG: 20 July 2017

Approval time: 236 working days

Dengue tetravalent vaccine-live, attenuated

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.

DARZALEX / JANSSEN DARATUMUMAB

Evaluation commenced: 30 November 2016

Registration decision: 12 July 2017

Entry onto ARTG: 17 July 2017

Approval time: 152 working days

daratumumab

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.

OCREVUS

Evaluation commenced: 30 June 2016

Registration decision: 3 July 2017

Entry onto ARTG: 13 July 2017

Approval time: 215 working days

ocrelizumab

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.

June 2017

There were no new entries for June.

May 2017

PHEBURANE

Evaluation commenced: 2 May 2016

Registration decision: 19 May 2017

Entry onto ARTG: 30 May 2017

Approval time: 225 working days

sodium phenylbutyrate

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).

LONSURF/ORCANTAS

Evaluation commenced: 2 February 2016

Registration decision: 19 May 2017

Entry onto ARTG: 23 May 2017

Approval time: 232 working days

trifluridine/tipiracil hydrochloride

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.

UROREC

Evaluation commenced: 31 May 2016

Registration decision: 18 May 2017

Entry onto ARTG: 23 May 2017

Approval time: 197 working days

silodosin

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.

REXULTI

Evaluation commenced: 29 April 2016

Registration decision: 17 May 2017

Entry onto ARTG: 19 May 2017

Approval time: 231 working days

brexipiprazole

Lundbeck Australia Pty Limited

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

REVESTIVE orphan drug

Evaluation commenced: 31 May 2016

Registration decision: 17 May 2017

Entry onto ARTG: 19 May 2017

Approval time: 196 working days

teduglutide

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.

KANUMA orphan drug

Evaluation commenced: 31 May 2016

Registration decision: 17 May 2017

Entry onto ARTG: 18 May 2017

Approval time: 220 working days

sebelipase alfa rce

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).

IBRANCE

Evaluation commenced: 31 May 2016

Registration decision: 28 April 2017

Entry onto ARTG: 3 May 2017

Approval time: 182 working days

palbociclib

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.

April 2017

AFSTYLA orphan drug

Evaluation commenced: 29 February 2016

Registration decision: 29 March 2017

Entry onto ARTG: 13 April 2017

Approval time: 228 working days

lonoctocog alfa (recombinant single-chain coagulation factor VIII)

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.

March 2017

REKOVELLE

Evaluation commenced: 29 February 2016

Registration decision: 24 March 2017

Entry onto ARTG: 31 March 2017

Approval time: 224 working days

follitropin delta (rhu)

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.

ADYNOVATE

Evaluation commenced: 29 April 2016

Registration decision: 15 March 2017

Entry onto ARTG: 21 March 2017

Approval time: 180 working days

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

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.

ALECENSA orphan drug

Evaluation commenced: 4 April 2016

Registration decision: 10 March 2017

Entry onto ARTG: 14 March 2017

Approval time: 210 working days

alectinib

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.

GRAZAX

Evaluation commenced: 29 January 2016

Registration decision: 24 February 2017

Entry onto ARTG: 7 March 2017

Approval time: 231 working days

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

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.

February 2017

ZEMAIRA orphan drug

Evaluation commenced: 31 March 2016

Registration decision: 9 February 2017

Entry onto ARTG: 13 February 2017

Approval time: 177 working days

human alpha-1-proteinase inhibitor

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.

January 2017

VENCLEXTA

Evaluation commenced: 29 February 2016

Registration decision: 15 December 2016

Entry onto ARTG: 5 January 2017

Approval time: 179 working days

venetoclax

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.