By Elias Schisgall
Novo Nordisk received a warning from the Food and Drug Administration for failing to report serious suspected side effects in patients who took the company's GLP-1 treatments.
The FDA in a Thursday letter underscored cases including two deaths and a suicide linked to patients taking semaglutide, which Novo markets as Ozempic and Wegovy.
The agency said Novo Nordisk inappropriately invalidated one case and failed to report the other two to the FDA. The agency didn't conclude whether the deaths were linked to the GLP-1 drug.
The FDA said Novo's policies around reporting suspected side effects were inconsistent with FDA regulations. It added that other adverse events were inappropriately invalidated or not submitted to the FDA within the required 15-day timeframe.
The FDA's findings were based on an inspection of a Novo facility conducted in early 2025. The agency acknowledged Novo's corrective and preventive actions since the inspection, but said the company's responses didn't ensure that future violations would be prevented.
"Your explanations, when taken into consideration with the violations described above and your failure to adequately address your noncompliance, suggest systemic failures with your surveillance, receipt, evaluation, and reporting of ADEs to FDA," the agency said in the letter.
The FDA gave Novo 15 days to notify the agency of actions it will take to prevent future violations.
Novo Nordisk said it is working quickly to respond to the FDA's request, adding that it has been regularly communicating with the agency about its corrective and preventative action plan. It said the letter does not make conclusions about the quality or safety of Novo's treatments.
"Over the past year, Novo Nordisk has undertaken a broad, multi?pronged effort to address the FDA PADE inspection-closing potential gaps while building durable and scalable pharmacovigilance capability," the company said. "We are confident that we will be able to respond to the requests in the Warning Letter to the Agency's full satisfaction."
The letter comes as Novo battles with Eli Lilly for dominance in the rapidly growing weight-loss and diabetes drug market. The two companies have been cutting prices and racing to release pill versions of the drugs in an effort to expand their shares of the roughly $72 billion global market for the treatments.
Novo had an early lead in the market over Lilly, but Lilly has since pulled ahead, The Wall Street Journal has reported.
Shares of Novo were down 3.4% to $38.43 as of late Tuesday morning.
Write to Elias Schisgall at elias.schisgall@wsj.com
(END) Dow Jones Newswires
03-10-26 1215ET
