European Drug Authority Raises Thyroid Cancer Safety Signal For Novo Nordisk Drugs, Including Hyped Semaglutide

The EU's drugs watchdog, the European Medicines Agency, recently raised a thyroid cancer safety signal for Novo Nordisk A/S NVO drugs, including the much talked semaglutide used in Ozempic and Wegovy for weight loss.

The safety signal indicates the EMA's monitoring of potential adverse events related to approved drugs but does not establish causation between the medicine and 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.

Also Read: Novo Nordisk Takes Legal Action Against Wellness Clinics for False Advertising of Weight Loss Drug.

But a "causal association" between semaglutide and thyroid cancer had not been demonstrated in large-scale clinical trials and post-marketing surveillance," he said.

Andersen-Lange said the Danish media 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.

Competitors Eli Lilly And Co LLY, AstraZeneca plc AZN, and Sanofi SA SNY are also included in the EMA's safety signal.

The companies have until July 26 to provide additional information requested by the EMA.

Semaglutide's label mentions thyroid tumors in rodents, but the effects on humans are unknown. The FDA advises against taking Wegovy if the patient has a family history of thyroid cancer.

Price Action: NVO shares are down 0.65% at $159.50 during the premarket session on the last check Thursday.