In response to growing reports of patient harm caused by counterfeit versions of its popular diabetes drug, Ozempic (semaglutide), Novo Nordisk A/S's
Jorgensen emphasized the gravity of the situation, stating, "This is something we take very seriously."
The surge in demand for Novo's drugs, particularly those promoting weight loss, has outpaced supply, raising concerns about unregulated and counterfeit medicines globally.
The Partnership for Safe Medicines, an anti-counterfeiting group, has identified counterfeit Ozempic in 16 countries.
Disturbing reports obtained through Freedom of Information Act (FOIA) requests indicate patient harm in Belgium, Iraq, Serbia, and Switzerland due to fake Ozempic consumption, Reuters highlighted.
While Ozempic is primarily approved for diabetes treatment, its shared active ingredient with Novo's weight-loss drug Wegovy has led to off-label use for weight loss.
The World Health Organization has linked global shortages of these drugs to a rise in suspected counterfeit incidents.
The report further noted that last week, FDA head Robert Califf highlighted the likelihood of more cases of online sales of counterfeit obesity drugs than reported.
Novo's reports to the FDA revealed cases of dangerous drops in blood sugar after patients took suspected or confirmed fake Ozempic.
CEO Jorgensen expressed concern about compounded semaglutide in the U.S., pointing to the risks associated with raw materials from unregulated Asian facilities.
Reports obtained through FOIA requests highlighted one fatality last year linked to abnormal blood clotting after using a drug falsely advertised as compounded semaglutide.
In December, the FDA said it was investigating counterfeit Ozempic injection of 1mg in the legitimate U.S. drug supply chain and has seized thousands of units of the diabetes drug.
Amid shortage, Friday, Novo Nordisk's Wegovy garnered the FDA's approval for expanded use for reducing risks of major adverse cardiovascular events, including cardiovascular death, non-fatal heart attack (myocardial infarction), or non-fatal stroke in adults with either overweight or obesity and established cardiovascular disease.
Price Action: NVO shares are down 1.01% at $131.72 on the last check Monday.