Section A: Premarket registration applications
At this meeting, the committee provided advice on 11 applications under evaluation by the TGA, as below.
| Active ingredient (TRADE NAME) | 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) | |||
| rozanolixizumab (RYSTIGGO) | UCB Australia Pty Ltd Australia T/A UCB Pharma Division of UCB | Generalised Myasthenia Gravis | |
| teprotumumab (TEPEZZA) | Amgen Australia Pty Ltd | Thyroid Eye Disease | Priority |
| tezepelumab (TEZSPIRE) | AstraZeneca Pty Ltd | Asthma | |
| palopegteriparatide (YORVIPATH) | Specialised Therapeutics Pharma Pty Ltd | Hypoparathyroidism | Orphan Priority |
| garadacimab (ANDEMBRY) | CSL Behring Australia Pty Ltd | Hereditary Angioedema | Orphan |
| Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C) | |||
| dapagliflozin propanediol monohydrate (FORXIGA) | AstraZeneca Pty Ltd | Chronic Kidney Disease | |
| blinatumomab (BLINCYTO) | Amgen Australia Pty Ltd | B-Cell precursor acute lymphoblastic leukemia | |
| pegcetacoplan (SYFOVRE) | Apellis Australia Pty Ltd | Geographic atrophy secondary to age-related macular degeneration | |
| dupilumab (DUPIXENT) | Sanofi-Aventis Australia Pty Ltd | Chronic Obstructive Pulmonary Disease | Priority |
The dates of commencement of the evaluation of these applications are available at Prescription medicines: applications under evaluation.
The committee also provided advice on:
- two applications for major variations (new dosage form, change/increase in patient group, change in dosage, new strength, new route of administration) (Application Type F)
Further details of the ACM discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs).
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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