Novo Nordisk (NVO) shares took a hit Thursday after reports that the European Medicines Agency is investigating a possible link between its Type 2 diabetes drug, Ozempic, and thyroid cancer.
The potential link, or safety signal, was identified in a November 2022 study, and the EMA said it was discussed as early as January during the approval process.
A safety signal "can be defined as information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. Signals are generated from several sources such as spontaneous reports, clinical studies, and the scientific literature," the EMA said in a statement to Yahoo Finance Thursday.
Novo Nordisk pushed back on the study in a statement, saying that it had several limitations and failed to establish a direct link between the GLP-1 drugs, medicines to treat type 2 diabetes, and the cancer risk.
Drugs like Ozempic and Wegovy "have been used to treat type 2 diabetes for more than 15 years and for treatment of obesity for 8 years, including Novo Nordisk products such as semaglutide (Ozempic, Rybelsus) and liraglutide (Saxenda) that have been on the market for more than 10 years. The safety data collected from large clinical trial programs and post marketing surveillance have not demonstrated a causal association between semaglutide or liraglutide and thyroid cancer," the company told Yahoo Finance.
In addition, Novo Nordisk said it has been complying with the EMA's requests for information and will continue to do so.
"Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials, real-world use and other relevant information in relation to these products and collaborates closely with the authorities to ensure patient safety and adequate information to prescribers and patients," the company said.
The EMA has also asked for ongoing information for the class of drugs from Eli Lilly (LLY), AstraZeneca (AZN) and Sanofi (SNY). The FDA, meanwhile, has known about potential links between the drug class and thyroid cancer risks, and set up a surveillance program after Novo Nordisk's Saxenda approval in 2010.
EMA said it's advisory committee, known as PRAC, is "reviewing the available evidence and the signal procedure is currently ongoing. EMA will communicate further if necessary."
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