The medications in question are glucagon-like peptide-1 (GLP-1) receptor agonists. Their manufacturers, including Novo Nordisk, AstraZeneca, Eli Lilly, and Sanofi Winthrop, must submit supplementary information by July 26, 2023.
A safety signal does not necessarily imply a direct causal relationship between a medicine and the reported adverse event. The purpose of assessing safety signals is to determine whether such a causal link exists between the medication and the reported adverse event.
“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, said in a statement to The Epoch Times.
According to Andersen-Lange, Novo Nordisk's products, including semaglutide, have been available in the market for over a decade, and the safety data gathered from clinical trials and postmarketing surveillance have not shown any conclusive evidence linking them to thyroid cancer.
The Study That Led to the Drug Safety AlertThe case-control analysis was conducted by a group of French researchers who analyzed data from the French national health care insurance system database and observed an increased risk of thyroid cancer among individuals using these drugs, particularly after one to three years of treatment.
Novo Nordisk has warned patients about the risk of thyroid C-cell tumors associated with the use of Ozempic or Wegovy. In the prescribing information, the manufacturer noted that semaglutide caused “dose-dependent and treatment-duration-dependent thyroid C-cell tumors" in rodents, but its impact on human cancer remains undetermined.
Rivalry Intensifies in GLP-1 Drug MarketSince the introduction of Wegovy in the United States in June 2021, the market value of Novo Nordisk has risen by more than 140 percent. Semaglutide has played a crucial role in Novo Nordisk's success. The company now holds the position of the second most valuable company in Europe, trailing behind only the French luxury goods group LVMH.
Other pharmaceutical companies, including Pfizer and Eli Lilly, have also been developing drugs from the GLP-1 family.
Mounjaro, with its active substance tirzepatide, acts similarly to semaglutide by targeting two hormones, glucose-dependent insulinotropic polypeptide (GIP) and GLP-1, to suppress appetite and reduce food intake.
GlobalData forecasts that Mounjaro, with its significant weight loss effects, has the potential to surpass Ozempic or Wegovy as the leading therapy for obesity and Type 2 diabetes. It is expected to gain possible FDA approval later in 2023 for obesity treatment.