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Prescription medicines: applications under evaluation
20 January 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update, if the medicine application has been decided (approved or rejected for registration), or when the applicant has withdrawn the application.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
| [1] | If the submission is withdrawn prior to the TGA's receipt of the sponsor's response to the Delegate's overview or request for expert advice, then an AusPAR will not be published. |
|---|
Applications under evaluation
Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market
Priority review: involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Provisional registration: involves early access to vital and life-saving medicines through time-limited registration
Displaying 1 - 25 of 108
Accepted for evaluation in December 2022
Application type: C (new indication)
Medicine name: YERVOY
Applicant: Bristol-Myers Squibb Australia Pty Ltd
Active ingredient(s): ipilimumab
Proposed Indication: For treatment of oesophageal carcinoma
Application type: B (new combination)
Medicine name: RYEQO
Applicant: Gedeon Richter Australia Pty Ltd
Active ingredient(s): relugolix; estradiol hemihydrate; norethisterone acetate
Proposed Indication: For treatment of uterine fibroids
Application type: A (new medicine)
Medicine name: EVUSHELD
Applicant: AstraZeneca Pty Ltd
Active ingredient(s): cilgavimab; tixagevimab
Proposed Indication: For treatment of COVID-19
Application type: C (new indication)
Medicine name: CABOMETYX
Applicant: Ipsen Pty Ltd
Active ingredient(s): cabozantinib (s)-malate
Proposed Indication: For treatment of thyroid carcinoma
Accepted for evaluation in November 2022
Application type: C (new indication)
Medicine name: SPIKEVAX
Applicant: Moderna Australia Pty Ltd
Active ingredient(s): elasomeran
Proposed Indication: Active immunisation for COVID-19
Application type: C (new indication)
Medicine name: SKYRIZI
Applicant: Abbvie Pty Ltd
Active ingredient(s): risankizumab
Proposed Indication: For treatment of Crohn's disease
Application type: C (new indication)
Medicine name: RINVOQ
Applicant: Abbvie Pty Ltd
Active ingredient(s): upadacitinib
Proposed Indication: For treatment of ulcerative colitis
Application type: A (new medicine)
Medicine name: RADICAVA
Applicant: Teva Pharma Australia Pty Ltd
Active ingredient(s): edaravone
Proposed Indication: For treatment of amyotrophic lateral sclerosis (ALS)
Application type: A (new medicine)
Medicine name: PAXLOVID
Applicant: Pfizer Australia Pty Ltd
Active ingredient(s): PF-07321332; ritonavir
Proposed Indication: For treatment of COVID-19
Application type: C (new indication)
Medicine name: OPDIVO
Applicant: Bristol-Myers Squibb Australia Pty Ltd
Active ingredient(s): nivolumab
Proposed Indication: For treatment of oesophageal carcinoma
Application type: C (new indication)
Medicine name: KEYTRUDA
Applicant: Merck Sharp & Dohme (Australia) Pty Ltd
Active ingredient(s): pembrolizumab (rch)
Proposed Indication: For treatment of renal cell carcinoma
Application type: C (new indication)
Medicine name: KEYTRUDA
Applicant: Merck Sharp & Dohme (Australia) Pty Ltd
Active ingredient(s): pembrolizumab (rch)
Proposed Indication: For treatment of triple-negative breast cancer (TNBC)
Application type: A (new medicine)
Medicine name: DOPTELET
Applicant: Swedish Orphan Biovitrum Pty Ltd
Active ingredient(s): avatrombopag maleate
Proposed Indication: For treatment of thrombocytopenia
Application type: C (new indication)
Medicine name: BRUKINSA
Applicant: Beigene Aus Pty Ltd
Active ingredient(s): zanubrutinib
Proposed Indication: For treatment of marginal zone
lymphoma (MZL)
Accepted for evaluation in October 2022
Application type: B (new combination)
Medicine name: TBC
Applicant: Abbvie Pty Ltd
Active ingredient(s): foscarbidopa; foslevodopa
Proposed Indication: For treatment of Parkinson's disease
Application type: A (new medicine)
Medicine name: KORSUVA
Applicant: Vifor Pharma Pty Ltd
Active ingredient(s): difelikefalin
Proposed Indication: For treatment of pruritus associated with chronic kidney disease
Application type: A (new medicine)
Medicine name: KIMMTRAK
Applicant: Adjutor Healthcare Pty Ltd
Active ingredient(s): tebentafusp
Proposed Indication: For treatment of unresectable or metastatic uveal melanoma
Application type: C (new indication)
Medicine name: KEYTRUDA
Applicant: Merck Sharp & Dohme (Australia) Pty Ltd
Active ingredient(s): pembrolizumab
Proposed Indication: For treatment of persistent, recurrent, or metastatic cervical cancer
Application type: C (new indication)
Medicine name: ACTEMRA
Applicant: Roche Products Pty Ltd
Active ingredient(s): tocilizumab (rch)
Proposed Indication: For treatment of COVID-19
Accepted for evaluation in September 2022
Application type: A (new medicine)
Medicine name: TBA
Applicant: AstraZeneca Pty Ltd
Active ingredient(s): tezepelumab
Proposed Indication: For maintenance treatment of severe asthma
Application type: A (new medicine)
Medicine name: REGKIRONA
Applicant: Celltrion Healthcare Australia Pty Ltd
Active ingredient(s): regdanvimab
Proposed Indication: For treatment of Covid-19
Application type: A (new medicine)
Medicine name: PEMAZYRE
Applicant: Incyte Biosciences Australia Pty Ltd
Active ingredient(s): pemigatinib
Proposed Indication: For treatment of cholangiocarcinoma
Application type: B (new combination)
Medicine name: OPDUALAG
Applicant: Bristol-Myers Squibb Australia Pty Ltd
Active ingredient(s): nivolumab; relatlimab
Proposed Indication: For treatment of unresectable or metastatic melanoma
Application type: C (new indication)
Medicine name: LIBTAYO
Applicant: Sanofi-Aventis Australia Pty Ltd
Active ingredient(s): cemiplimab
Proposed Indication: For treatment of metastatic basal cell carcinoma
Application type: C (new indication)
Medicine name: LIBTAYO
Applicant: Sanofi-Aventis Australia Pty Ltd
Active ingredient(s): cemiplimab
Proposed Indication: For treatment of metastatic cervical cancer