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.