(Reuters) – A thyroid cancer safety signal was raised by the EU’s drugs watchdog last month over several Novo Nordisk (NYSE:NVO) drugs including semaglutide which is used in popular diabetes and obesity drugs Ozempic and Wegovy, the company said on Thursday.
The European Medicines Agency (EMA) raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs. A signal from the EMA does not mean that the medicine is the cause of any reported adverse events.
“Novo Nordisk is aware of the signal and the request by EMA and will deliver a thorough assessment of all relevant data to elucidate this topic,” Lars Otto Andersen-Lange, media relations director at Novo Nordisk, told Reuters.
Shares in Denmark’s Novo were down 2% at 0916 GMT in a weaker Copenhagen market after Danish media outlet B.T. reported the EMA safety signal.
Andersen-Lange said the B.T. report referred to a May 8 statement from EMA, which raised a thyroid cancer safety signal for several drugs in the GLP-1 class, including semaglutide.
But a “causal association” between semaglutide and thyroid cancer had not been demonstrated in large-scale clinical trials and post-marketing surveillance, he said.
“Patient safety has top priority for Novo Nordisk, and we take all reports about adverse events from use of our medicines very seriously,” Andersen-Lange added.
An EMA spokesperson told Reuters that in January the agency’s safety committee had “discussed a signal for medicines pertaining to the glucagon-like peptide-1 (GLP-1) receptor agonists class, including medicines containing the active substance semaglutide.”
The spokesperson said the discussion followed the publication of a study suggesting that there might be an increased risk of thyroid cancers with the use of these drugs in patients with Type 2 diabetes.
EMA’s safety signal also included GLP-1 drugs from competitors Eli Lilly (NYSE:LLY), Astrazeneca (LON:AZN) and Sanofi (NASDAQ:SNY).
The three companies did not immediately respond to Reuters’ requests for comment on Thursday.
The companies have until July 26 to provide supplementary information requested by EMA in April, the agency said.
Both EMA and its U.S. equivalent, the FDA, mention on Wegovy’s label that semaglutide causes thyroid tumours in rodents but say the effects on humans are unknown. The FDA advises against taking Wegovy if the patient has a family history of thyroid cancer.
“It is probably far too early to raise a very strong concern about this. But it’s a good thing that they are looking into it,” Sydbank analyst Soren Lontoft Hansen told Reuters.
Sales of products based on semaglutide made up nearly 44% of total sales for Novo Nordisk in 2022.
