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ACM meeting statement, Meeting 57, 5 June 2026

Advisory Committee on Medicines
Published

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)SponsorTherapeutic areaApplication 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)

depemokimab

(EXDENSUR)

GlaxoSmithKline Australia Pty LtdChronic Rhinosinusitis with Nasal Polyps (CRSwNP) 

The dates of commencement of the evaluation of these applications are available at Prescription medicines: Applications under evaluation. 

The committee also provided advice on:

  • one application for major variations (new dosage form, change/increase in patient group, change in dosage, new strength, new route of administration) (Application Type F).
  • 1 nomination for the Medicines Repurposing Program.

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 

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