Section A: Premarket registration applications
At this meeting, the committee provided advice on 7 applications under evaluation by the TGA, as below.
The dates of commencement of the evaluation of these applications are available at Prescription medicines: applications under evaluation, see: 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).
- 1 nomination for the Medicines Repurposing Program (MRP).
Further details of the ACM discussion and advice associated with these items may be released within the Australian Public Assessment Reports (AusPARs). Browse all Australian Public Assessment Reports (AusPAR).
Section B: Post-market items
Glucagon-Like-Peptide-1 Receptor Agonists and Suicidal or Self-Injurious Ideation
Glucagon-Like-Peptide-1 Receptor Agonists (GLP-1 RAs) are a class of medicines that include: semaglutide, tirzepatide, liraglutide, and dulaglutide. These medicines are indicated for glycaemic control in Type 2 Diabetes Mellitus (T2DM), with some GLP-1 RAs also indicated for weight management, and for reducing the risk of major adverse cardiovascular events.
The Therapeutic Goods Administration (TGA) and international regulators identified a potential safety signal of GLP-1 RAs and a risk of suicidal or self-injurious ideation and behaviour. The ACM was asked to provide advice on whether the available evidence was sufficient to support an association between GLP-1 RAs and suicidal/self-injurious ideation. Advice was also requested on the need for regulatory action, such as updates to Product Information (PI) documents.
The ACM noted the complex interplay between mental illness and chronic endocrine disorders for which GLP-1 RAs may be used for treatment, and the potential relationship between weight loss and suicidal/self-injurious ideation.
The ACM discussed the Australian adverse event reports, the TGA literature review and limitations of current published literature, and ongoing investigations by international regulators. Ultimately, the ACM advised that the evidence available was not sufficient to support an association between GLP-1 RAs and suicidal or self-injurious ideation.
The ACM additionally noted that the Australian PIs for GLP-1 RAs contained inconsistent information about the potential risk of suicidal/self-injurious ideation. The advantages and disadvantages of aligning the PIs were discussed, including the importance of validating community concerns weighed against the potential risks of causing undue alarm where evidence is lacking. The ACM advised that harmonisation of statements regarding suicidal ideation in PIs for all GLP-1 RA products would be beneficial. The statements should not imply a causal association but reflect a class level awareness.
Further information
For further information on the Advisory Committee on Medicines, please visit: Advisory Committee on Medicines (ACM) or contact the ACM Secretary by email: ACM@health.gov.au.