Section A: Pre-market registration applications referred for advice
At this meeting, the committee’s advice was sought on 7 applications under evaluation by the TGA. The applications included:
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area |
|---|---|---|
| Type A (new biological entity) | ||
| aducanumab (ADUHELM) | Biogen Australia Pty Ltd | For treatment of Alzheimer’s disease |
| Type C (extension of indications) | ||
| dupilumab (DUPIXENT) | Sanofi Aventis Australia Pty Ltd | For the treatment of asthma |
| nitric oxide (INOMAX) | Ikaria Australia Pty Ltd | For the treatment of a respiratory condition |
| rivaroxaban (XARELTO) | Bayer Australia Pty Ltd | For the treatment of VTE |
*These application types are published on Prescription medicines: applications under evaluation.
In addition to:
- One for the registration of a new chemical entity (accepted for evaluation prior to the publication of applications under evaluation)
- One seeking a major variation (change in dosage)
- 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. Browse all AusPARs.
Further information
For further information visit the Advisory Committee on Medicines or contact the ACM Secretary by email: ACM@health.gov.au.