The European Medicines Agency (EMA) said on Tuesday it has extended its probe into Novo Nordisk’s NOVOb.CO diabetes drugs Ozempic and weight-loss treatment Saxenda, following two reports of suicidal thoughts, to include other drugs in the same class.
The agency began its review on July 3 after Iceland’s health regulator flagged the reports of patients thinking about suicide and one case of thoughts of self harm after use of Novo’s drugs.
There have been issues of suicidal thoughts linked to another class of weight-loss drugs, which have hobbled previous attempts by the drug industry to develop lucrative weight-loss drugs.
Sanofi’s weight-loss drug Acomplia, which never won U.S. approval, was withdrawn in Europe in 2008 after being linked to suicidal thoughts.
The EMA said on Tuesday it will now investigate the class of drugs known as GLP-1 receptor agonists, which trigger a feeling of fullness after eating. The review is expected to complete in November, according to the agency.
Drugmaker Eli Lilly’s LLY.N shares closed down 3.1%. Its diabetes drug Trulicity also belongs to the same class.
Novo’s weight-loss drug Wegovy, which contains active ingredient semaglutide, is also part of the review.
Other GLP-1 drugs include Sanofi’s SASY.PA Suliqua and AstraZeneca’s AZN.L Bydureon. Both are approved in Europe for treatment of type 2 diabetes.
Sanofi said it has not identified any safety concerns related to “suicidal ideation” from use of its GLP-1 receptor agonist. However, the company has started an investigation and will share all relevant information with the European health regulator.
Lilly and AstraZeneca did not immediately respond to Reuters’ requests for comment.
The European health regulator is also investigating GLP-1 drugs for possible risk of thyroid cancer.
(Reporting by Bhanvi Satija and Khushi Mandowara in Bengaluru and Maggie Fick in London; Editing by Maju Samuel, Shinjini Ganguli and Shounak Dasgupta)
Comments