Novo Nordisk’s blockbuster weight-loss drug Wegovy was approved on Friday by the FDA to reduce the risk of cardiovascular death, heart attack and stroke in adults who have cardiovascular disease and are obese or overweight.
Pictured: Novo Nordisk’s headquarters in Copenhagen, Denmark iStock/Ole Schwander
Novo Nordisk’s weight-loss drug Wegovy (semaglutide) on Friday secured a label expansion from the FDA. The regulator approved a new indication for the blockbuster GLP-1 to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and who are obese or overweight.
The FDA said Wegovy should be combined with a reduced calorie diet and physical activity. The regulator also noted in its announcement that the safety and efficacy of the new indication were based on a trial that had over 17,600 patients either on Wegovy or a placebo, as well as standard medical treatment and lifestyle counseling.
The results showed that Wegovy had reduced the risk of major adverse cardiovascular events, occurring in 6.5% of the trial participants compared to 8% of the patients who had the placebo, according to the FDA.
“Wegovy is now the first weight-loss medication also to be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” John Sharretts, the director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a statement. “This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option proven to lower this cardiovascular risk is a major advance for public health.”
Novo reported Wegovy’s effect on cardiovascular health in November 2023 with results from the Phase III SELECT trial. A 2.4mg injection of Wegovy led to a 20% drop in major adverse cardiovascular events compared to placebo when added to standard of care.
However, Novo’s Friday announcement of the FDA’s label expansion for Wegovy acknowledged that “the exact mechanism of cardiovascular risk reduction has not been established.” The company said it has also filed for a label expansion in the European Union, with a decision expected in 2024.
“This approval is an important milestone for people living with obesity and cardiovascular disease, as the SELECT data demonstrated that Wegovy has the potential to prolong lives by addressing some of the leading causes of preventable deaths by reducing the risks of cardiovascular events,” Martin Holst Lange, executive vice president and head of development at Novo Nordisk, said in a statement.
The label expansion for Wegovy comes as Novo reported a considerable spike in profit in 2023, thanks to robust sales of its GLP-1 drugs.
However, the Danish pharma is looking for ways to boost the production of these drugs as demand continues to outpace supply. Last year, Novo announced that it would make a $6 billion investment in manufacturing. It has also turned to acquiring production capabilities with Novo Nordisk Foundation’s buy last month of contract manufacturer Catalent for $16.5 billion, which resulted in three facilities going to Novo Nordisk for $11 billion to bolster GLP-1 production.
Novo is also pursuing other weight-loss candidates. This week, it reported Phase I results for a next-generation therapy called amycretin, which saw a 13.1% reduction in weight loss versus 1.1% for placebo.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
