EU Watchdog Seeks More Data From GLP-1 Drugmakers on Suicidal Thoughts


The EU’s drug watchdog will request more data from makers of a class of diabetes and weight-loss drugs including Novo Nordisk’s (NOVOb.CO) popular therapies Ozempic and Wegovy to further investigate suicidal thoughts in some patients taking them.

“While at this point no conclusion can be drawn on a causal association, there are several issues that still need to be clarified,” the European Medicines Agency (EMA) said in a statement on Friday.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will discuss the topic again at its meeting in April 2024, it added.

The move follows a review that started in July and covered a range of drugs known as GLP-1 receptor agonists, also including Eli Lilly’s (LLY.N) Trulicity, Sanofi’s (SASY.PA) Suliqua, AstraZeneca’s (AZN.L) Bydureon and Novo’s Rybelsus and Saxenda.

The issue was discussed this week by PRAC, which monitors drugs’ side effects and which holds monthly meetings.

EMA had initially received reports from the Icelandic Medicines Agency, based on two cases involving liraglutide, the active ingredient in Saxenda, and one case for semaglutide, the active ingredient in Ozempic and Wegovy.

The review was also based on at least 170 case reports from EudraVigilance, a system to register suspected adverse reactions to medicines.

Demand for Novo’s obesity drug Wegovy as well as diabetes drug Ozempic, which is widely used off-label, has overwhelmed the Danish drugmaker and has left it scrambling to boost output.

The drug’s most common side effects are gastrointestinal conditions.

Though also targeting the GLP-1 receptor, Eli Lilly’s diabetes and weight-loss drug Mounjaro, also known as Zepbound, is not part of EMA’s review because it belongs to a different molecule class that binds to two different gut hormone receptors.

Novo said it would “continue to collaborate closely with the authorities to investigate any issues that may need to be clarified”. Astra, Lilly and Sanofi did not immediately respond to a request for comment.

Source : Reuters