The European Union has given its approval to Novo Nordisk's Wegovy for lowering heart risk.

• The European Union's medical regulator has approved the use of Novo Nordisk's Wegovy weight loss drug to reduce the risk of serious heart events in overweight and obese adults.
• The European Medical Agency has given a "positive opinion" on the label expansion of the Danish pharmaceutical giant, following the review of the outcomes of the closely monitored SELECT trial.

The European Union's medical regulator has approved the use of Novo Nordisk's Wegovy weight loss drug to reduce the risk of serious heart events in overweight and obese adults.

The European Medical Agency has given a "positive opinion" on the label expansion of the Danish pharmaceutical giant's drug after reviewing the outcomes of the SELECT trial, paving the way for additional applications.

The SELECT trial, funded by Novo Nordisk and published in August 2023, revealed that semaglutide, the active ingredient in Wegovy and Ozempic, reduced the risk of major cardiovascular events by 20% compared to a placebo.

Novo Nordisk's executive vice president and head of development, Martin Holst Lange, stated that the recommendation to update the EMA label for Wegovy is a significant milestone for people living with cardiovascular disease and obesity.

"Wegovy not only aids in weight management but also has the potential to save lives by decreasing the likelihood of severe cardiovascular events."

The label update for the SELECT trial revealed a 15% reduction in cardiovascular death and a 19% reduction in death from any cause when the product was used, compared to placebo use, the company stated.

Novo Nordisk said it expects to implement the label update within a month.

The UK's medical regulator has approved the use of Wegovy to reduce the risk of serious heart problems and strokes in overweight and obese adults.

In March, the U.S. Food and Drug Administration approved the drug for additional uses, increasing the range of applications for the widely used medicine amid intensifying competition in the industry.

Roche announced on Thursday that its Wegovy competitor weight loss drugs will be included in a collection of medications aimed at treating obesity.

Thomas Schinecker, CEO of the company, expressed excitement over the positive early stage trial results of the two weight loss drug candidates, stating that they have the "best in disease potential." He emphasized that these drugs will be part of a broader portfolio aimed at setting the company apart from competitors in the growing obesity medication market.