Section A: Premarket registration applications
At this meeting, the committee provided advice on 15 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) | |||
| andexanet alfa (ANDEXXA) | AstraZeneca Pty Ltd | For treatment of reversal of anticoagulation | Provisional |
| atogepant (AQUIPTA) | AbbVie Pty Ltd | For the treatment of migraines | |
| olipudase alfa (XENPOZYME) | Sanofi-Aventis Australia Pty Ltd | For the treatment of non-central nervous system (CNS) manifestations of acid sphingomyelinase deficiency (ASMD) | Orphan |
| capmatinib (TABRECTA) | Novartis Pharmaceuticals Australia Pty Ltd | For treatment of non-small cell lung cancer | Orphan |
| imlifidase (IDEFIRIX) | Hansa Biopharma Pty Ltd | For desensitisation treatment | Provisional Orphan |
| selpercatinib (RETEVMO) | Eli Lilly Australia Pty Ltd | For the treatment of non-small cell lung cancer | Provisional |
| tafasitamab (MINJUVI) | Specialised Therapeutics Alim Pty Ltd | For the treatment of Diffuse Large B-cell Lymphoma (DLBCL) | Provisional Orphan |
| Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C) | |||
| cefuroxime sodium (CEFINTRA) | Aspen Pharmacare Australia Pty Ltd | For treatment of postoperative endophthalmitis | |
| clobetasol propionate (XOBET) | Douglas Pharmaceuticals Australia | For treatment of steroid responsive dermatoses | |
| dapagliflozin (FORXIGA) | AstraZeneca Pty Ltd | For the treatment of heart failure | |
| dupilumab (DUPIXENT) | Sanofi-Aventis Australia Pty Ltd | For the treatment of prurigo nodularis (PN) | |
| dupilumab (DUPIXENT) | Sanofi-Aventis Australia Pty Ltd | For the treatment of severe atopic dermatitis in patients aged 6 months to 11 years | |
| sacituzumab govitecan (TRODELVY) | Gilead Sciences Pty Ltd | For the treatment of breast cancer | Priority |
| upadacitinib (RINVOQ) | AbbVie Pty Ltd | For the treatment of Crohn's disease | |
| zoledronic acid (Multiple tradenames) | Arrotex Pty Ltd | For the treatment of breast cancer in postmenopausal women | |
The dates of commencement of the evaluation of these applications are available at Prescription medicines: applications under evaluation, see: <https://www.tga.gov.au/prescription-medicines-applications-under-evaluation>
The committee also provided advice on:
- 1 application for variation to the registered entry resulting in a change to the PI (Application Type J)
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: <https://www.tga.gov.au/resources/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:
<https://www.tga.gov.au/about-tga/advisory-bodies-and-committees/advisory-committee-medicines-acm>
or contact the ACM Secretary by email: ACM@health.gov.au