(Adds background in paragraphs 5-14)
By Ludwig Burger
Dec 1 (Reuters) – The EU’s drug watchdog will request more data from makers of a class of diabetes and weight-loss drugs including Novo Nordisk’s 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, making it the first major global regulator to provided an update on such reviews.
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 Trulicity, Sanofi’s Suliqua, AstraZeneca’s 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.
Reuters reported in September that the U.S. Food and Drug Administration (FDA) had received 265 reports of suicidal thoughts or behaviour in patients taking GLP-1 medication between 2010 and June 2023.
The FDA said at the time it was reviewing such reports to decide on what action, if any, to take.
Britain
has been reviewing the potential side-effect since July.
Issues of suicidal thoughts 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Sanofi’s weight-loss drug Acomplia, which never won U.S. approval, was withdrawn in Europe in 2008 after being linked to suicidal thoughts.
But obesity experts have said that reduced calorie intake as a result of strict dieting or gastric surgery can also lead to depression in rare cases.
The class of drugs known as GLP-1 receptor agonists trigger a feeling of fullness after eating and slow gastric emptying.
(Additional reporting by Yadarisa Shabong Editing by Frances Kerry)
