The European Union drug regulator found no evidence that a class of diabetes and weight-loss drugs such as Novo Nordisk’s NOVOb.CO hugely popular Wegovy, are linked to suicidal thoughts, it said on Friday following a nine-month probe.
After reviewing the available evidence, the European Medicines Agency (EMA)’s Pharmacovigilance Risk Assessment Committee, which monitors drugs’ side effects said that no updates to the product information is warranted.
The finding comes after EMA extended in December its review into the class of weight-loss and diabetes drugs known as GLP-1 receptor agonists, to get more data from drugmakers to further investigate the issue.
The analysis started in July after Iceland’s health regulator flagged three cases of patients thinking about suicide or self-harm after using Novo’s drugs. The review focused on medicines that contain either semaglutide or liraglutide, both GLP-1 targeting compounds.
Liraglutide is the active ingredient in Novo’s weight-loss treatment Saxenda while semaglutide is the active ingredient in Wegovy and top-selling diabetes treatment Ozempic.
EMA also analysed about 170 other case reports on suspected adverse reactions registered with the EU’s EudraVigilance database.
The U.S. Food and Drug Administration’s preliminary review in January had found no link between GP-1 drugs and suicidal thoughts or actions.
GLP-1 receptor agonists, originally developed to help control blood sugar in patients with diabetes in Novo’s Nordisk’s Ozempic and Mounjaro developed by Eli Lilly LLY.N, also slow digestion and reduce hunger.
(Reuters)
