Section A: Premarket registration applications
At this meeting, the committee provided advice on 10 applications under evaluation by the TGA, as below.
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area | Application designations |
|---|---|---|---|
| Applications for a 'new medicine' containing a new active substance (new chemical entity or new biological entity) not currently approved in Australia (Application Type A) | |||
apadamtase alfa / cinaxadamtase alfa (ADZYNMA) | Takeda Pharmaceuticals Australia Pty Ltd | Congenital thrombotic thrombocytopenic purpura | Orphan |
cefiderocol sulfate tosilate (FETROJA) | Accelagen Pty Ltd | Antibiotic in adults with limited treatment options | |
seladelpar lysine dihydrate (LIVDELZI) | Gilead Sciences Pty Ltd | Primary biliary cholangitis in adults | |
| Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C) | |||
Darolutamide (NUBEQA) | Bayer Australia Ltd | Metastatic hormone-sensitive prostate cancer | |
Pembrolizumab (KEYTRUDA) | Merck Sharp & Dohme (Australia) Pty Ltd | Head and neck squamous cell carcinoma | |
lenacapavir sodium (YEYTUO) | Gilead Sciences Pty Ltd | HIV pre-exposure prophylaxis in adults | Priority |
Buprenorphine (SUBLOCADE MODIFIED RELEASE SOLUTION FOR INJECTION) | Indivior Pty Ltd | Opioid dependence | |
Guselkumab (TREMFYA) | Janssen-Cilag Pty Ltd | Moderate to severe plaque psoriasis in children aged 6 years and older | |
acalabrutinib maleate monohydrate (CALQUENCE) | AstraZeneca Pty Ltd | Chronic lymphocytic leukaemia / small lymphocytic lymphoma | |
Iptacopan (FABHALTA) | Novartis Pharmaceuticals Australia Pty Ltd | Paroxysmal nocturnal haemoglobinuria and complement 3 glomerulopathy in adults | Orphan Priority |
The dates of commencement of the evaluation of these applications are available at Prescription medicines: applications under evaluation, see: Prescription medicines: Applications under evaluation.
The committee also provided advice on:
- 1 nomination for the Medicines Repurposing Program
- 1 general request for advice on monitoring requirements for an approved medicine.
Further details of the ACM discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs). To browse all AusPARs see: Australian Public Assessment Reports (AusPAR).
Section B: Post-market items
The ACM was not asked to provide advice on a post-market or safety issue.
Further information
For further information on the Advisory Committee on Medicines, please visit: Advisory Committee on Medicines (ACM) or contact the ACM Secretary by email: ACM@health.gov.au.