There is no evidence of an increased risk of suicidal or self-injurious thoughts and actions with GLP-1 agonists used to treat diabetes amd obesity, according to the EU medicines regulator.
Along with other world regulators – including the FDA in the US, the UK MHRA and Health Canada – the EMA started its review of the safety of the fast-growing class last year after reports of suicidal thoughts or self-injury in a small number of patients taking them.
The investigation was a big concern for companies like Novo Nordisk and Eli Lilly, which have multibillion-dollar franchises based on GLP-1 drugs. It looked into several big-selling therapies including Novo Nordisk’s Ozempic for diabetes and obesity therapy Wegovy, both of which are based on semaglutide, and Lilly’s diabetes therapy Trulicity (dulaglutide).
The EMA’s verdict endorses the preliminary result of the FDA’s review, which also found no link with thoughts of suicide or self-injury when it concluded in January, just a few days after it started. The US investigation is still ongoing, however, and has been broadened to include Lilly’s dual GLP-1/GIP agonist tirzepatide, approved as Mounjaro for obesity and Zepbound for obesity.
Both investigations were prompted by a report from the Icelandic Medicines Agency that highlighted three possible cases among patients taking Ozempic or Novo Nordisk’s older GLP-1 drug Saxenda (liraglutide) for weight loss.
The EU regulator’s Pharmacovigilance Risk Assessment Committee (PRAC) looked at the results of two studies, based on large databases of electronic health records among patients taking GLP-1 agonists, which found no causal association.
One has been published in the journal Nature Medicine and looked at records from more than 240,000 patients, finding no increase in risk compared to non-GLP-1 agonist therapies for diabetes and obesity.
Also included in the EMA’s review was Saxenda and two other Novo Nordisk diabetes therapies – Rybelsus (semaglutide) and Xultophy (insulin degludec and liraglutide) – along with AstraZeneca’s Byetta (exenatide) and Bydureon (exenatide) and Sanofi’s Lyxumia (lixisenatide) and Suliqua (insulin glargine and lixisenatide).
“After reviewing the available evidence from non-clinical studies, clinical trials, post-marketing surveillance data and the available studies, the PRAC considers that no update to the product information is warranted,” said the EMA in a statement.
It added however that the manufacturing authorisation holders (MAHs) for GLP-1 agonists will “continue to monitor these events closely.”
Last year, the PRAC also concluded there was no increased risk of thyroid cancer with Ozempic and Trulicity in a separate review.
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