PTC Web Desk: The European Union's drug regulatory body has requested additional information from pharmaceutical companies such as Novo Nordisk A/S and Eli Lilly & Co. as part of its ongoing evaluation concerning the potential risk of suicidal thoughts linked to a novel category of weight-loss drugs.
Initiated in July, the European Medicines Agency (EMA) investigation was prompted by reported instances of suicidal thoughts and self-harm among individuals using weight-loss medications. The focus of the review is on GLP-1 treatments, a group encompassing Novo's Wegovy weight-loss injection and its diabetes medication Ozempic. These drugs hold a prominent position in the pharmaceutical market.
In a statement released on Friday, the EMA's safety committee mentioned that it had scrutinised all available clinical trial data and published literature regarding this matter. However, while no definitive correlation has been established at this stage, the committee highlighted several unresolved queries that require clarification.
The committee has formulated additional sets of inquiries to be addressed by the manufacturers of these medications. It indicated a plan to revisit this topic during its meeting in April.
Despite their recent adoption for weight management purposes, GLP-1 drugs have a history of over 15 years as treatments for diabetes. Notably, the EMA's investigation also encompasses dulaglutide, an active component in Lilly's diabetes medication Trulicity, and AstraZeneca Plc's diabetes drug Byetta.
Ensuring patient safety remains a top priority for Lilly, as stated by a company spokesperson to Bloomberg on Friday. The company affirmed its commitment to addressing regulatory reviews concerning safety signals associated with dulaglutide within its standard regulatory assessment protocols.