Boxes of Ozempic and Wegovy made by Novo Nordisk are seen at a pharmacy.
Hollie Adams | Reuters
Novo Nordisk’s blockbuster Wegovy weight loss drug has received backing from the European Union’s medical regulator to expand the medicine’s use to include reducing the rise of serious heart events in overweight and obese adults.
The Danish pharmaceutical giant on Thursday said that the European Medical Agency had adopted a “positive opinion” on the label expansion after reviewing the outcomes of a closely watched SELECT trial, opening the door to 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 — cut the risk of major cardiovascular events by 20% compared with a placebo.
“We believe that the recommendation to update the EMA label for Wegovy is a significant milestone for people living with cardiovascular disease and obesity,” Novo Nordisk’s executive vice president and head of development, Martin Holst Lange, said in a statement.
“The SELECT data demonstrated that in addition to helping people manage their weight, Wegovy has the potential to protect lives by reducing the risks of major adverse cardiovascular events.”
The label update also includes data from the SELECT trial showing a risk reduction in cardiovascular death by 15% and a risk reduction of death from any cause by 19%, compared to instances when a placebo was used, the company said.
Novo Nordisk said it expects to implement the label update within a month.
It follows similar moves by the UK’s medical regulator, which on Tuesday approved the use of Wegovy to reduce the risk of overweight and obese adults suffering from serious heart problems or strokes.
The U.S. Food and Drug Administration in March also approved the drug for such applications, expanding the use cases of the highly popular medicine as competition heats up in the sector.
Swiss pharmaceuticals giant Roche on Thursday said that its Wegovy rival weight loss drugs will be part of a suite of medicines aimed at combating the effects of obesity.
The company’s CEO Thomas Schinecker welcomed positive early stage trial results from the firm’s two weight loss drug candidates as showing “best in disease potential.” He added that they will form part of a wider portfolio aimed at differentiating the Swiss company from other competitors in the growing obesity medication market.