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Prescription medicines: applications under evaluation

19 April 2022

This page provides a list of applications for new medicines or new uses for existing medicines that are currently under evaluation by the TGA. The list of medicines under evaluation is updated each month.

Information on three types of applications is included:

  • Application type A: applications for a 'new medicine' containing a new active substance (new chemical entity or new biological entity) not currently approved in Australia
  • Application type B: applications for a 'new combination', where two or more already approved medicines are combined into a single product
  • Application type C: applications for a 'new indication', or additional therapeutic use, for an already approved medicine

Applications for new generic and biosimilar medicines are excluded from this list.

The entry for each application includes:

  • the proposed tradename
  • the applicant name
  • the active ingredient(s)
  • a summary of the proposed indication(s)
  • the application type

Publication commenced for applications accepted for evaluation from January 2021. The list only includes medicines that have been accepted for evaluation and are under evaluation with a cut-off the day the report is completed. Entries are removed from the list as part of the monthly update, if the medicine application has been decided (approved or rejected for registration), or when the applicant has withdrawn the application.

You can see if an application has been approved by searching the Australian Register of Therapeutic Goods (ARTG).

Further information about decisions (approved and rejected) and some withdrawals[1] is available in form of an Australian Public Assessment Report (AusPAR) or a Decision summary.

IMPORTANT INFORMATION

Medicines are listed on this page when they are accepted for evaluation by the TGA. It is important to view the information in the context of the following.

Evaluation does not guarantee registration

The list only includes information on medicines that are currently under evaluation for quality, safety and efficacy and are pending the decision to register the medicine on the ARTG.

Not all medicines that are accepted for evaluation are approved by the TGA. Whether a medicine is approved or not depends on the outcomes of our assessment of the application.

The medicine's indications can also change following our evaluation of the data. For more information visit our web page on new registrations.

Evaluation does not guarantee PBS listing

While entry on the ARTG provides for legal supply of a medicine in Australia, the listing of the medicine on the Pharmaceutical Benefits Scheme (PBS) facilitates subsidised access to medicines. PBS listing is subject to a separate application process that is also initiated by the company and typically follows the registration on the ARTG. For information about PBS listings visit the PBS website.

Each year the TGA accepts approximately 100 major innovator applications for new medicines or new uses of medicines.


Footnotes


Applications under evaluation


symbol denoting an orphan drug

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

symbol denoting a priority determination

Priority review: involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available

symbol denoting a provisional registration

Provisional registration: involves early access to vital and life-saving medicines through time-limited registration


Displaying 101 - 125 of 135

Enter medicine name, applicant name, indication, or active ingredient

Accepted for evaluation in April 2021

Application type: A (new medicine)
Medicine name: ILLUCCIX
Applicant: Telix Pharmaceuticals (ANZ) Pty Ltd
Active ingredient(s): glu-urea-lys(ahx)-hbed-cc
Proposed Indication: For use in imaging of patients diagnosed with prostate cancer.
Application type: A (new medicine)
Medicine name: ADUHELM
Applicant: Biogen Australia Pty Ltd
Active ingredient(s): aducanumab
Proposed Indication: For treatment of Alzheimer's disease.

Accepted for evaluation in March 2021

Application type: C (new indication)
Medicine name: ZEPOSIA
Applicant: Celgene Pty Ltd
Active ingredient(s): ozanimod hydrochloride
Proposed Indication: For the treatment of active ulcerative colitis
Application type: A (new medicine)
Medicine name: XEMBIFY
Applicant: Grifols Australia Pty Ltd
Active ingredient(s): human immunoglobulin a
Proposed Indication: For the treatment of primary immunodeficiency syndroms.
Application type: C (new indication)
Medicine name: WEGOVY
Applicant: Novo Nordisk Pharmaceuticals Pty Ltd
Active ingredient(s): semaglutide
Proposed Indication: For weight management
Application type: A (new medicine)
Medicine name: VUMERITY
Applicant: Biogen Australia Pty Ltd
Active ingredient(s): diroximel fumarate
Proposed Indication: For the treatment of relapsing multiple sclerosis.
provisional registration orphan drug
Application type: A (new medicine)
Medicine name: TBA
Applicant: Merck Sharp & Dohme (Australia) Pty Ltd
Active ingredient(s): belzutifan
Proposed Indication: For the treatment of patients with von Hippel-Lindau (VHL)
Application type: C (new indication)
Medicine name: OPDIVO
Applicant: Bristol-Myers Squibb Australia Pty Ltd
Active ingredient(s): nivolumab
Proposed Indication: For the treatment of gastric adenocarcinoma.
orphan drug
Application type: A (new medicine)
Medicine name: LUMAKRAS
Applicant: Amgen Australia Pty Ltd
Active ingredient(s): sotorasib
Proposed Indication: For the treatment of non-small cell lung cancer
priority review orphan drug
Application type: C (new indication)
Medicine name: JAKAVI
Applicant: Novartis Pharmaceuticals Australia Pty Ltd
Active ingredient(s): ruxolitinib phosphate
Proposed Indication: For the treatment of patients with Graft versus Host Disease (GvHD)
Application type: C (new indication)
Medicine name: INVEGA HAFYERA
Applicant: Janssen-Cilag Pty Ltd
Active ingredient(s): paliperidone palmitate
Proposed Indication: For the treatment of schizophrenia
Application type: A (new medicine)
Medicine name: BIMZELX
Applicant: UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia
Active ingredient(s): bimekizumab
Proposed Indication: For the treatment of plaque psoriasis

Accepted for evaluation in February 2021

Application type: C (new indication)
Medicine name: VERZENIO
Applicant: Eli Lilly Australia Pty Ltd
Active ingredient(s): abemaciclib
Proposed Indication: Adjuvent therapy for breast cancer.
Application type: A (new medicine)
Medicine name: TBA
Applicant: Merck Sharp & Dohme (Australia) Pty Ltd
Active ingredient(s): pneumococcal purified capsular polysaccharides
Proposed Indication: For active immunisation for the prevention of pneumococcal disease.
Application type: A (new medicine)
Medicine name: SAPHNELO
Applicant: AstraZeneca Pty Ltd
Active ingredient(s): anifrolumab
Proposed Indication: For the treatment of systemc lupus erythematosus.
Application type: C (new indication)
Medicine name: RYALTRIS
Applicant: Seqirus Pty Ltd
Active ingredient(s): mometasone furoate monohydrate; olopatadine hydrochloride
Proposed Indication: For the treatment of symptoms associated with allergic rhinitis and rhinoconjunctivitis
Application type: C (new indication)
Medicine name: OPDIVO
Applicant: Bristol-Myers Squibb Australia Pty Ltd
Active ingredient(s): nivolumab
Proposed Indication: Adjuvent therapy for oesophageal cancer or gastro-oesophageal junction cancer.
provisional registration
Application type: A (new medicine)
Medicine name: NUVAXOVID
Applicant: Biocelect Pty Ltd
Active ingredient(s): SARS-CoV-2rs (NVX-CoV2373)
Proposed Indication: Active immunisation for COVID-19
Application type: C (new indication)
Medicine name: NUCALA
Applicant: GlaxoSmithKline Australia Pty Ltd
Active ingredient(s): mepolizumab
Proposed Indication: For the treatment of chronic rhinosinusitis with nasal polyps.
Application type: C (new indication)
Medicine name: NPLATE
Applicant: Amgen Australia Pty Ltd
Active ingredient(s): romiplostim
Proposed Indication: For the treatment of thrombocytopenia
Application type: C (new indication)
Medicine name: MAVIRET
Applicant: Abbvie Pty Ltd
Active ingredient(s): glecaprevir; pibrentasvir
Proposed Indication: For the treatment of chronic hepatitis C virus
provisional registration
Application type: A (new medicine)
Medicine name: JEMPERLI
Applicant: GlaxoSmithKline Australia Pty Ltd
Active ingredient(s): dostarlimab
Proposed Indication: Therapy for endometrial cancer.
Application type: C (new indication)
Medicine name: JARDIANCE
Applicant: Boehringer Ingelheim Pty Ltd
Active ingredient(s): empagliflozin
Proposed Indication: For the treatment of heart failure.
Application type: C (new indication)
Medicine name: COSENTYX
Applicant: Novartis Pharmaceuticals Australia Pty Ltd
Active ingredient(s): secukinumab
Proposed Indication: For the treatment of plaque psoriasis.

Accepted for evaluation in January 2021

Application type: C (new indication)
Medicine name: UTROGESTAN
Applicant: Besins Healthcare Australia Pty Ltd
Active ingredient(s): progesterone
Proposed Indication: For the prevention of miscarriage

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