A pharmacy can see boxes of Ozempic and Wegovy made by Novo Nordisk.
Holly Adams | Reuters
Novo Nordisk’s blockbuster Wegovy weight loss drug has won support from EU medical regulators to expand its uses to include reducing the incidence of serious heart events in overweight and obese adults.
Danish pharmaceutical giant Thursday explain The European medical agency took a “positive opinion” on the label extension after reviewing results from the closely watched SELECT trial, opening the door for further applications for the drug.
Results from the Novo Nordisk-funded SELECT trial, published in August 2023, found that semaglutide (the active ingredient in Wegovy and Ozempic) reduced the risk of major cardiovascular events by 20% compared with placebo.
“We believe the recommendation to update the EMA label is an important milestone for people living with cardiovascular disease and obesity,” Martin Holst Lange, executive vice president and head of development at Novo Nordisk, said in a statement.
“The SELECT data demonstrate that in addition to helping people manage their weight, Wegovy has the potential to protect lives by reducing the risk of major adverse cardiovascular events.”
The label update also includes data from the SELECT trial, which showed a 15% reduction in the risk of cardiovascular death and a 19% reduction in the risk of all-cause death compared with placebo, the company said.
Novo Nordisk said it expects to implement the labeling update within a month.
UK medical regulators have previously taken similar steps, with Tuesday Approved for use with Wegovy Reduces the risk of serious heart disease or stroke in overweight and obese adults.
U.S. Food and Drug Administration March The drug has also been approved for such applicationsAs competition in the industry increases, use cases for the popular drug have expanded.
Swiss pharmaceutical giant Roche said on Thursday that its Wegovy rival weight loss drug will become part of a suite of drugs designed to combat the effects of obesity.
Chief Executive Thomas Schinecker welcomed positive early-stage trial results for the company’s two weight-loss drug candidates, saying they showed “optimal disease potential.” They will form part of a broader product portfolio designed to differentiate the Swiss company from rivals in the growing obesity drug market, he added.
