The European Medicines Agency (EMA) is intensifying its scrutiny of a class of diabetes and weight-loss drugs, including Novo Nordisk’s Ozempic and Wegovy, for possible links to suicidal thoughts in patients.
This action follows a review initiated in July, encompassing drugs like Eli Lilly’s Trulicity, Sanofi’s Suliqua, AstraZeneca’s Bydureon, and Novo’s Rybelsus and Saxenda, all classified as GLP-1 receptor agonists. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) plans to revisit this topic in April 2024.
The investigation was spurred by reports from the Icelandic Medicines Agency and additional cases registered in EudraVigilance, a European system for monitoring suspected drug side effects.
Although the EMA has not concluded a direct causal relationship, the need for further data and clarification remains. Notably, Eli Lilly’s Mounjaro (Zepbound) is not included in this review due to its distinct molecular classification.
The EMA’s ongoing investigation into GLP-1 receptor agonists could have significant repercussions for the pharmaceutical and biotech industries, particularly for companies like Novo Nordisk and Eli Lilly.
In the next 12 months, this scrutiny may lead to heightened regulatory oversight, potential labeling changes, and an impact on prescribing practices.
