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Section A: Premarket registration applications
At this meeting, the committee provided advice on 5 applications under evaluation by the TGA, as below.
| Active ingredient (TRADENAME) | Sponsor | Therapeutic area | Application designations |
|---|---|---|---|
| Applications for a 'new combination', where two or more already approved medicines are combined into a single product (Application Type B) | |||
vanzacaftor / tezacaftor / deutivacaftor (ALYFTREK) | Vertex Pharmaceuticals Australia Pty Ltd | Cystic fibrosis | Orphan |
| Applications for a 'new indication', or additional therapeutic use, for an already approved medicine (Application Type C) | |||
spesolimab (SPEVIGO) | Boehringer Ingelheim Pty Ltd | Generalised pustular psoriasis | |
| onasemnogene abeparvovec (ZOLGENSMA) | Novartis Pharmaceuticals Australia Pty Ltd | Symptomatic or pre-symptomatic spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene | |
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:
- 1 application for major variations (new dosage form, change/increase in patient group, change in dosage, new strength, new route of administration) (Application Type F).
- 1 application for transition from provisional approval to full registration (Application Type S).
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: Australian Public Assessment Reports (AusPAR).
Section B: Post-market items
GLP-1 receptor agonist products (GLP-1 RAs) and non-arteritic anterior ischaemic optic neuropathy (NAION)
Glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) are a class of medicines that include: semaglutide (OZEMPIC, WEGOVY, RYBELSUS), tirzepatide (MOUNJARO), liraglutide (SAXENDA, VICTOZA, XULTOPHY), and dulaglutide (TRULICITY). Many of these medicines are used in the treatment of type 2 diabetes mellitus. Some are used in overweight and obesity for weight management, reducing the risk of major adverse cardiovascular events, and treatment of moderate to severe sleep apnoea.
The Therapeutic Goods Administration (TGA) has identified a potential safety signal for non-arteritic anterior ischemic optic neuropathy (NAION) associated with GLP-1 RAs. This signal has emerged from multiple sources including media reports, sponsor notifications, reporting to the TGA’s adverse event database, and reviews by international regulatory agencies.
The European Medicines Agency has recently recommended listing NAION as a very rare side effect of semaglutide (may affect up to 1 in 10,000 people who take semaglutide).
Currently, NAION is not listed as a potential side effect for GLP-1 RAs in Australia, the United States, the United Kingdom, or Canada. The TGA’s investigation has found that the available evidence of an association was mixed.
The ACM discussed that approximately 97% of cases of NAION share one major ophthalmic risk factor (disc at risk), which can be screened for by an optometrist or ophthalmologist. The ACM noted that screening may be difficult in some individuals with certain medical conditions, but the benefit of GLP-1 RAs for these patients may still outweigh the very rare risk of NAION. The ACM advised that ophthalmic risks occur with several medicines and emphasised the incidence of NAION remains very rare.
The ACM noted that most of the current literature has assessed the association between NAION and semaglutide specifically. The ACM concluded that the evidence may support the signal for semaglutide, but not dulaglutide or tirzepatide.
The ACM recommended various risk mitigation strategies, including:
- Updates to the Product Information and Consumer Medicines Information documents.
- A Medicines Safety Update published on the TGA website.
- Communication from the TGA and/or Sponsor to relevant healthcare providers (general practitioners, optometrists, and ophthalmologists).
The ACM advised that communication to optometrists may be particularly valuable in mitigating the risk of this very rare side effect.
The ACM acknowledged the public concern regarding this very rare side effect and believed the proposed risk mitigation strategy would better allow patients to be appropriately informed of the potential risks involved with treatment without causing undue alarm.
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.