Section A: Premarket registration applications
At this meeting, the committee provided advice on 14 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) | |||
| avacopan (TAVNEOS) | Vifor Pharma Pty Ltd | For treatment of vasculitis | Orphan |
| edaravone (RADICAVA) | Teva Pharma Australia Pty Ltd | For treatment of amyotrophic lateral sclerosis (ALS) | Orphan |
| prabotulinumtoxinA (NUCEIVA) | PPD Australia Pty Ltd | For treatment of glabellar lines | |
| pralsetinib (GAVRETO) | Roche Products Pty Ltd | For treatment of lung cancer | Provisional |
| pralsetinib (GAVRETO) | Roche Products Pty Ltd | For treatment of thyroid cancer | Provisional |
| tirzepatide (MOUNJARO) | Eli Lilly Australia Pty Ltd | For treatment of type 2 diabetes mellitus | |
| Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C) | |||
| baricitinib (OLUMIANT) | Eli Lilly Australia Pty Ltd | For treatment of alopecia areata | |
| ivacaftor (KALYDECO) | Vertex Pharmaceuticals | For treatment of cystic fibrosis | Orphan |
| polatuzumab vedotin (POLIVY) | Roche Products Pty Ltd | For treatment of lymphoma | |
| tofacitinib (XELJANZ) | Pfizer Australia Pty Ltd | For treatment of anklyosing spondylitis | |
| upadacitinib (RINVOQ) | AbbVie Pty Ltd | For treatment of axial spondyloarthritis | |
The dates of commencement of the evaluation of these applications are available at Prescription medicines: applications under evaluation, see: <https://www.tga.gov.au/prescription-medicines-applications-under-evaluation>
The committee also provided advice on:
- One application for the registration of a new biosimilar medicine
- Two applications for major variations (new dosage form, change/increase in patient group, change in dosage, new strength, new route of administration) (Application Type F)
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: <https://www.tga.gov.au/resources/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:
<https://www.tga.gov.au/about-tga/advisory-bodies-and-committees/advisory-committee-medicines-acm>
or contact the ACM Secretary by email: ACM@health.gov.au