Novo Nordisk (NVO) said Wednesday the European Commission granted marketing authorization for Wegovy pill for the treatment of adults with obesity or overweight with at least one weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity.
The approval makes Wegovy pill the first GLP-1 receptor agonist available in tablet form for weight management in the European Union. The company said the authorization is the fifth for Wegovy pill after approvals in the US, UK, UAE and Bahrain.
The approval was based on the Oasis clinical trial program, including the phase 3b Oasis 4 trial. In that trial, once-daily oral semaglutide 25 mg demonstrated about 17% weight loss compared with 3% for placebo when used alongside lifestyle intervention.
The European Commission also approved Wegovy 7.2 mg injection in a single-dose pen for people living with obesity. Novo Nordisk said it plans to launch Wegovy pill in additional countries in H2.
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