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ACM meeting statement, Meeting 55, 5 February 2026

Advisory Committee on Medicines
Published

Section A: Premarket registration applications

At this meeting, the committee provided advice on 6 applications under evaluation by the TGA.

Active ingredient (TRADENAME)SponsorTherapeutic areaApplication 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)
clesrovimab 
(ENFLONSIA)		Merck Sharp & Dohme (Australia) Pty LtdPrevention of respiratory syncytial virus (RSV) in newborns and infants 
tolebrutinib
(CENRIFKI)		Sanofi-Aventis Australia Pty LtdNon-relapsing secondary progressive multiple sclerosis (nrSPMS) in adultsPriority
Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C)
obinutuzumab
(GAZYVA)		Roche Products Pty LtdActive lupus nephritis in adults 
daratumumab
(DARZALEX SC)		Janssen-Cilag Pty LtdMultiple myeloma 
finerenone
(KERENDIA)		Bayer Australia LtdHeart failure with left ventricular ejection fraction (LVEF) of ≥ 40% in adults 
semaglutide
(WEGOVY)		Novo Nordisk Pharmaceuticals Pty LtdNon-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH)Provisional

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.

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