Section A: Premarket registration applications
At this meeting, the committee provided advice on 14 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) | |||
mirikizumab (OMVOH) | Eli Lilly Australia Pty Ltd | For treatment of moderately to severely active ulcerative colitis |
|
spesolimab (SPEVIGO) | Boehringer Ingelheim Pty Ltd | For treatment of generalised pustular psoriasis. | Orphan |
tirbanibulin (ONAKTA) | Seqirus Pty Ltd | For the topical field treatment of actinic keratosis. |
|
vadadustat (VAFSEO) | Adjutor Healthcare Pty Ltd | For treatment of anaemia associated with chronic kidney disease. |
|
Applications for a 'new combination', where two or more already approved medicines are combined into a single product (Application Type B) | |||
foslevodopa and foscarbidopa (TBA at time of commencement of evaluation) | AbbVie Pty Ltd | For treatment of Parkinson's disease. |
|
Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C) | |||
apremilast (OTEZLA) | Amgen Australia Pty Ltd | For the treatment of adult patients with oral ulcers and plaque psoriasis. |
|
dabrafenib (TAFINLAR) | Novartis Pharmaceuticals Australia Pty Ltd | For treatment of glioma. |
|
trametinib (MEKINIST) | Novartis Pharmaceuticals Australia Pty Ltd | For treatment of glioma. |
|
melatonin (IMELLA, MELATONIN-LINK, RYLAKSO, VOQUILLY) | Link Medical Products Pty Ltd | For treatment of jet lag and sleep disorders |
|
olaparib (LYNPARZA) | AstraZeneca Pty Ltd | For treatment of prostate cancer |
|
secukinumab (COSENTYX) | Novartis Pharmaceuticals Australia | For treatment of hidradenitis suppurativa |
|
somapacitan (SOGROYA) | Novo Nordisk Pharmaceuticals Pty Ltd | For the extension of indications to include paediatric patients |
|
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:
- 2 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). 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