Novo Nordisk says EMA raised safety signal on drugs including semaglutide
Reuters
Published Jun 22, 2023 08:58
Updated Jun 22, 2023 14:08
By Nikolaj Skydsgaard
COPENHAGEN (Reuters) -A thyroid cancer safety signal was raised by the EU's drugs watchdog last month over several Novo Nordisk (CSE:NOVOb) products including semaglutide, which is used in popular diabetes and obesity medicines Ozempic and Wegovy.
The European Medicines Agency (EMA) raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs, Novo Nordisk said. Such 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 initially fell more than 2% but were down 1% at 1230 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 (NASDAQ:AZN) and Sanofi (EPA:SASY). The companies have until July 26 to provide supplementary information requested in April, EMA said.
A spokesperson for Lilly said the U.S. firm has previously acknowledged the risk of thyroid cancer related to GLP-1 drugs and is working with regulatory agencies to conduct two studies investigating that link.
The spokesperson also said Eli Lilly had received the EMA's request in April and would respond to the questions by July 26.
AstraZeneca and Sanofi did not immediately respond to Reuters' requests for comment.
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.
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"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.
Written By: Reuters
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