The EU Ozempic probe is expanding. What you should know – National | 24CA News
The European Medicines Agency (EMA) stated on Tuesday it has prolonged its probe into Novo Nordisk’s NOVOb.CO diabetes medication Ozempic and weight-loss therapy Saxenda, following two reviews of suicidal ideas, to incorporate different medication in the identical class.
The company started its evaluation on July 3 after Iceland’s well being regulator flagged the reviews of sufferers occupied with suicide and one case of ideas of self hurt after use of Novo’s medication.
There have been problems with suicidal ideas linked to a different class of weight-loss medication, which have hobbled earlier makes an attempt by the drug trade to develop profitable weight-loss medication.
Sanofi’s weight-loss drug Acomplia, which by no means gained U.S. approval, was withdrawn in Europe in 2008 after being linked to suicidal ideas.
The EMA stated on Tuesday it would now examine the category of medication often called GLP-1 receptor agonists, which set off a sense of fullness after consuming. The evaluation is anticipated to finish in November, based on the company.
Drugmaker Eli Lilly’s LLY.N shares closed down 3.1%. Its diabetes drug Trulicity additionally belongs to the identical class.
Novo’s weight-loss drug Wegovy, which accommodates energetic ingredient semaglutide, can also be a part of the evaluation.
Other GLP-1 medication embrace Sanofi’s SASY.PA Suliqua and AstraZeneca’s AZN.L Bydureon. Both are authorised in Europe for therapy of kind 2 diabetes.
Sanofi stated it has not recognized any security considerations associated to “suicidal ideation” from use of its GLP-1 receptor agonist. However, the corporate has began an investigation and can share all related info with the European well being regulator.
Lilly and AstraZeneca didn’t instantly reply to Reuters’ requests for remark.
The European well being regulator can also be investigating GLP-1 medication for doable threat of thyroid most cancers.
(Reporting by Bhanvi Satija and Khushi Mandowara in Bengaluru and Maggie Fick in London; Editing by Maju Samuel, Shinjini Ganguli and Shounak Dasgupta)
