Section A: Pre-market registration applications referred for advice
At this meeting, the committee’s advice was sought on 11 applications under evaluation by the TGA. The applications included:
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area |
|---|---|---|
| Type A (new biological entity) | ||
| letibotulinum toxin A (LETYBO) | CROMA Australia Pty Ltd | For treatment of glabellar frown lines.
|
| Type A (new chemical entity) | ||
| deucravacitinib (SOTYKTU) | Bristol-Myers Squibb Australia Pty Ltd | For the treatment of adult patients with moderate to severe plaque psoriasis. |
| icosapent ethyl (VAZKEPA) | AA-Med Pty Ltd | For reducing the risk of cardiovascular events.
|
| difelikefalin (KORSUVA) | Vifor Australia Pty Ltd | For treatment of pruritus associated with chronic kidney disease |
| Type B (new combination) | ||
| foslevodopa and foscarbidopa (VYALEV) | AbbVie Pty Ltd | For treatment of Parkinson’s disease. |
| Type C (extension of indications) | ||
| empagliflozin (JARDIANCE) | Boehringer Ingelheim | For treatment of symptomatic heart failure.
|
| migalastat (GALAFOLD) | Amicus Therapeutics Pty Ltd | For treatment of Fabry disease.
|
| cabozantinib (CABOMETYX) | Ipsen Pty Ltd | For treatment of thyroid carcinoma. |
| pembrolizumab (KEYTRUDA) | Merck Sharp and Dohme (Australia) Pty Ltd | For treatment of melanoma. |
*These application types are published on the Prescription medicines: applications under evaluation page https://www.tga.gov.au/prescription-medicines-applications-under-evaluation
In addition to:
- One for the transition from provisional to full registration.
- One for the registration of a new biosimilar medicine
Further details of the ACM discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs). Please note that there is a delay from when an application was considered at ACM and the publication of the AusPAR. To browse all AusPARs see: <https://www.tga.gov.au/resources/auspar>
Further information
For further information on the Advisory Committee on Medicines, please visit: https://www.tga.gov.au/committee/advisory-committee-medicines-acm or contact the ACM Secretary by email: ACM@health.gov.au.