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) | |||
| Bulevirtide acetate (HEPCLUDEX) | Gilead Sciences Pty Ltd | For the treatment of chronic hepatitis delta virus. | Orphan Priority |
| Lutetium (177Lu) vipivotide tetraxetan (PLUVICTO) | Novartis Pharmaceuticals Australia Pty Ltd | For the treatment of prostate cancer. | |
| Lecanemab (LEQEMBI) | Eisai Australia Pty Ltd | For the treatment of patients with Alzheimer’s disease. | |
| Linzagolix choline (YSELTY) | Theramex Australia Pty Ltd | For the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. | |
| Zilucoplan tetrasodium (TBC) | UCB Australia Pty Ltf T/A UCB Pharma Division of UCB Australia | For the treatment of adult patients with generalised myasthenia gravis (gMG). | |
| Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C) | |||
| Triamcinolone acetonide (ARCATUS) | Arctic Vision Australia Pty Ltd | For the treatment of macular oedema. | |
| Empagliflozin (JARDIANCE) | Boehringer Ingelheim Pty Ltd | For the treatment of type 2 diabetes. | |
| Empagliflozin, metformin hydrochloride (JARDIAMET) | Boehringer Ingelheim Pty Ltd | For the treatment of type 2 diabetes. | |
The dates of commencement of the evaluation of these applications are available at Prescription medicines: applications under evaluation, see: Prescription medicines: Applications under evaluation.
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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