The European Medicines Agency (EMA) is reviewing data on the potential effects of high-profile glucagon-like peptide-1 receptor agonists (GLP-1RAs), including Novo Nordisk’s Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide) in causing suicidal thoughts and thoughts of self-harm.
The EMA has previously approved these drugs for weight loss and/or as treatments for type 2 diabetes.
The EMA investigation comes after the Icelandic Medicines Agency flagged reports of suicidal thoughts and self-injury in patients taking Ozempic and Saxenda. Authorities are so far investigating 150 reports of possible cases of self-injury and suicidal thoughts.
Led by the Pharmacovigilance Risk Assessment Committee (PRAC), the EMA evaluation aims to find if these symptoms are linked to the medicines themselves, are unrelated or caused by other underlying factors. The EMA reports that more than 20 million patients in the EU have so far used liraglutide and semaglutide.
GLP-1RAs are a rapidly growing class of drugs with 28 therapies currently being investigated in Phase III trials, according to GlobalData. These medicines work by activating glucagon-like peptide 1, which increases insulin secretion from the pancreas, leading to a reduction in blood sugar and weight loss effects. With the success of blockbuster drugs such as Ozempic and Eli Lilly’s Mounjaro (tirzepatide), pharmaceutical giants such as Pfizer, Sanofi and Amgen are now rapidly developing clinical pipelines with their own GLP1RAs.
GlobalData reports that Novo Nordisk made approximately $8.4bn in global sales for Ozempic last year. The company predicts that global sales could increase to almost $11.6bn by the end of this year.
GlobalData is the parent company of Pharmaceutical Technology.
The EMA is conducting this review similar to a signal procedure. The regulator describes a signal as “a new adverse event that is potentially caused by a medicine or a new aspect of a known adverse event that warrants further investigation”. Currently, none of the EU drug labels for approved GLP-1RAs include information about any mental health-associated risks.
The EMA began the review of Ozempic on 3 July but has now extended it to include the entire class of GLP-1 receptor agonists. The agency plans to complete the review by November 2023.
The World Health Organisation (WHO) reports that one in four adolescents and nearly 60% of adults are overweight or obese in the WHO European region. WHO have released multiple action plans to mitigate the rising problem, but currently no member state is on track to meet the goal of stopping the rise in obesity by 2025.
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