Dive Brief:
- European Union regulators, worried that a new class of drugs including Novo Nordisk’s Ozempic may risk thoughts of self-harm or suicide, are broadening their review of the medicines.
- The safety committee began its examination on July 3 after three reports from Iceland of people taking either the diabetes treatment Ozempic or another drug in the class, Saxenda, who had thoughts of suicide or self-injury. Originally, the review only focused on those two products and Wegovy, which contains the same active ingredient as Ozempic but is approved for weight loss.
- Regulators now have about 150 reports of possible self-injury and suicidal thoughts, according to a statement released Tuesday. And they expanded the review to look at all of the drugs in the class, known as GLP-1 receptor agonists.
Dive Insight:
GLP-1 agonists have changed the treatment of diabetes and obesity, offering profound weight loss for patients and a multibillion-dollar opportunity for drugmakers led by Novo. The medicines brought in about 100 billion Danish kroner, or roughly $15 billion, in revenue for Novo last year.
But regulators want to make sure they understand all of the possible side effects, especially after the “fen-phen” controversy of the 1990s. In that case, half of a widely prescribed combination seen by some as a sort of magic treatment for weight loss was found to cause heart valve defects. The combination was later pulled off the market.
EU regulators said it’s not clear if the cases of self-harm and suicidal thoughts reported so far for patients on GLP-1 agonists are actually linked to the medicines or to other factors such as the patients’ underlying conditions. They expect to conclude their review in November.
Novo’s diabetes medicine Ozempic is the most well-known drug in the class, though it’s used off-label to treat obesity. Novo sells Wegovy and Saxenda for weight loss as well. Other GLP-1 agonists included in the EMA’s review are Eli Lilly’s Trulicity, AstraZeneca’s Bydureon and Sanofi’s Lyxumia.
Lilly also sells another diabetes drug, Mounjaro, that has shown promising results for weight loss. It targets GLP-1 as well as another receptor called GIP and wasn’t named in the EMA’s statement.