Section A: Premarket registration applications
At this meeting, the committee provided advice on 7 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) | |||
donanemab (KISUNLA) | Eli Lilly Australia Pty Ltd | Alzheimer’s Disease | |
Nemolizumab (NEMLUVIO) | Galderma Australia Pty Ltd | Atopic Dermatitis, Prurigo Nodularis | |
Omaveloxolone (SKYCLARYS) | Biogen Australia Pty Ltd | Friedrich’s Ataxia | Orphan |
Gadopiclenol (ELUCIREM/VUEWAY) | Guerbet Australia Pty Ltd | Contrast Magnetic Resonance Imaging | |
Pegunigalsidase alfa (ELFABRIO) | Chiesi Australia Pty Ltd | Fabry Disease | |
Lonapegsomatropin (SKYTROFA) | Specialised Therapeutics Pharma Pty Ltd | Growth Hormone Deficiency | |
| Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C) | |||
IncobotulinumtoxinA (XEOMIN) | Merz Australia Pty Ltd | Limb Spasticity | |
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.