Section A: Premarket registration applications
At this meeting, the committee provided advice on 7 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) | |||
Clascoterone (WINLEVI) | Sun Pharma ANZ Pty Ltd | For the treatment of acne vulgaris. |
|
Etranacogene dezaparvovec (HEMGENIX) | CSL Behring Australia Pty Ltd | For the treatment of adults with haemophilia B. | Provisional Orphan |
Indocyanine Green (VERDYE) | Regulatory Approval Services Pty Ltd | For diagnostic use only. |
|
Nelarabine (NELARABINE REACH) | Reach Pharmaceuticals Pty Ltd | For the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. | Orphan |
Sodium Zirconium Cyclosilicate Hydrate (LOKELMA) | AstraZeneca Pty Ltd | For the treatment of hyperkalaemia in adult patients. |
|
Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C) | |||
Bimekizumab (BIMZELX) | UCB Australia Pty Ltd | For the treatment of adult patients with active psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis. |
|
Eptacog alfa (activated) (NOVOSEVEN RT) | Novo Nordisk Pharmaceuticals Pty Ltd | For the treatment of severe postpartum haemorrhage. |
|
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
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