COPENHAGEN, June 22 Reuters Novo Nordisk said on Thursday the European Union39;s drug watchdog had last month raised a thyroid cancer safety signal for several of its drugs including semaglutide, the active ingredient in its popular diabetes and obesity drugs, Ozempic and Wegovy.
Shares in Denmark39;s Novo fell more than 2 in a weaker Copenhagen market after Danish media outlet B.T. reported that the European Medicines Agency EMA had raised the safety signal, which is a way to monitor potential adverse events from the use of approved drugs.
A signal from 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 AndersenLange, media relations director at Novo Nordisk, told Reuters.
AndersenLange 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 GLP1 class, including semaglutide.
But a causal association between semaglutide and thyroid cancer had not been demonstrated in largescale clinical trials and postmarketing 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, AndersenLange added.
EMA39;s safety signal had also included GLP1 drugs from competitors Eli Lilly, Astrazeneca and Sanofi. The three…