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Section A: Premarket registration applications
At this meeting, the Committee provided advice on 3 applications under evaluation by the TGA, as below.
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area | Application designation/ determination |
|---|---|---|---|
| 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) | |||
| sotagliflozin (INPEFA) | Viatris Pty Ltd | Heart failure | |
| icotrokinra hydrochloride (ICOTYDE) | Janssen-Cilag Pty Ltd | Plaque psoriasis | |
gadoquatrane (AMBELVIST) | Bayer Australia Ltd | Magnetic Resonance Imaging (MRI) contrast agents | |
olutasidenib (REZLIDHIA) | Dr Reddys Laboratories Australia Pty Ltd | Acute myeloid leukemia (AML) | Orphan |
| Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C) | |||
dupilumab (DUPIXENT) | Sanofi-Aventis Australia Pty Ltd | Bullous pemphigoid | Orphan |
fremanezumab (AJOVY) | Teva Pharma Australia Pty Ltd | Episodic migraine | |
human fibrinogen (RIASTAP) | CSL Behring (Australia) Pty Ltd | Acquired fibrinogen deficiency | |
risankizumab (SKYRIZI) | AbbVie Pty Ltd | Plaque psoriasis | |
The dates of commencement of the evaluation of these applications are available at Prescription medicines: applications under evaluation, see: Prescription medicines: Applications under evaluation.
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.