“Wegovy is the first weight loss drug approved for use in the prevention of life-threatening cardiovascular events in obese or overweight adults with cardiovascular disease,” said John Sharetz, director of the FDA's Center for Drug Evaluation and Research. said the M.D. Ph.D. Friday's statement.
“We are thrilled that Wigovy has been approved in the U.S. as the first treatment to help people manage their weight and reduce cardiovascular risk,” Martin Horst Lange, executive vice president of Novo Nordisk, said in a statement. Ta.
The FDA's expansion of Wegovy's regulatory label comes after a closely monitored clinical trial last year found the drug dramatically reduced the risk of heart disease in overweight people. Demand for Wigovy is so strong that Novo Nordisk has struggled to produce enough quantities, and the FDA has declared a shortage of the drug. The company is taking unprecedented measures to expand production, including acquiring manufacturing contractors.
This is a developing story and will be updated.