Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 January 2025

Purpose:

The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has initiated an investigation into medicines containing semaglutide to assess the risk of a rare eye condition known as non-arteritic anterior ischemic optic neuropathy (NAION). This review is prompted by two recent observational studies that suggest an increased risk of developing NAION in patients treated with semaglutide, while two other studies do not support this association. The primary objective of PRAC’s assessment is to determine whether the use of semaglutide may elevate the risk of NAION in patients, particularly those with type 2 diabetes who are already at a higher inherent risk of developing this condition.

Effects on Industry:

The investigation into medicines containing semaglutide will likely have significant implications for the pharmaceutical industry. Manufacturers of semaglutide-containing medications, such as Ozempic, Rybelsus, and Wegovy, may need to reevaluate their marketing strategies and product labeling in light of PRAC’s findings. Additionally, the review may lead to changes in clinical trial designs or post-marketing surveillance studies for these products. Pharmaceutical companies may also be required to implement additional safety measures or update their risk management plans to mitigate potential risks associated with semaglutide use.

Relevant Stakeholders:

The stakeholders affected by PRAC’s investigation include:

• Patients taking medicines containing semaglutide, particularly those with type 2 diabetes who are already at a higher inherent risk of developing NAION.
• Healthcare providers and physicians prescribing these medications to patients.
• Pharmaceutical manufacturers of semaglutide-containing products (e.g., Novo Nordisk, Eli Lilly).
• Regulatory agencies responsible for overseeing the approval and safety monitoring of pharmaceuticals.

Next Steps:

PRAC will conduct a comprehensive review of all available data on NAION in association with semaglutide use. This includes:

• Analyzing data from clinical trials.
• Examining post-marketing surveillance studies.
• Reviewing studies on the mechanism of action and medical literature, including the results of observational studies.
  PRAC will communicate further updates as necessary.

Any Other Relevant Information:

Chou et al. (2024), Simonsen et al. (2024), and Grauslund et al. (2024) are among the recent studies investigating the risk of NAION in association with semaglutide use. These studies have generated conflicting results, highlighting the need for PRAC’s thorough review to clarify the relationship between semaglutide and NAION.

References:

• Chou CC, Pan SY, Sheen YJ, Lin JF, Lin CH, Lin HJ, Wang IJ, Weng CH. Association between Semaglutide and Non-Arteritic Anterior Ischemic Optic Neuropathy: A Multinational Population-Based Real-World Study. Ophthalmology. 2024 Nov 2: S0161-6420(24)00685-7.
• Simonsen E., Lund LC, Thomsen Ernst M., Hjellvik V., Hegedüs L., Hamann S., Kalsnes Jørstad Ø., Løvdal Gulseth H., Karlstad Ø., Pottegård A. 2024 Dec 11 Use of semaglutide and risk of non-arteritic anterior ischemic optic neuropathy: A Danish–Norwegian cohort study medRxiv preprint doi: 10.1101/2024.12.09.24318574
• Grauslund, J., Abou Taha, A., Dehghani Molander, L., Kawasaki, R., Möller, S., Højlund, K., & Stokholm, L. Once-weekly semaglutide doubles the five-year risk of nonarteritic anterior ischemic optic neuropathy in a Danish cohort of 424,152 persons with type 2 diabetes, International Journal of Retina and Vitreous, accepted for publication