The European Commission approved Novo Nordisk A/S’ (NYSE:NVO) Wegovy pill, a once-daily oral semaglutide 25 mg treatment for adults with obesity or overweight with at least one weight-related comorbidity.
The approval makes Wegovy the first GLP-1 receptor agonist available in tablet form for weight management across all European Union member states.
The approval covers adults with a body mass index (BMI) of at least 30 kg/m² or at least 27 kg/m² with one or more weight-related comorbidities, to be used alongside a reduced-calorie diet and increased physical activity.
It follows a positive opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use in May 2026.
European Commission Approves First Oral GLP-1 Therapy For Weight Management
The latest decision marks the fifth regulatory approval for the Wegovy pill after previous authorizations in the United States, the U.K., the United Arab Emirates, and Bahrain.
The European Commission also approved the Wegovy 7.2 mg injection in a single-dose pen for obesity.
Novo Nordisk said it plans to introduce the treatment in additional countries during the second half of 2026.
Clinical Trial Data Show Significant Weight Loss With Oral Semaglutide
The approval was supported by the OASIS clinical trial program, including the OASIS 4 study, which evaluated once-daily oral semaglutide 25 mg in adults with obesity or overweight and at least one weight-related comorbidity.
According to the company, participants receiving oral semaglutide achieved approximately 17% weight loss compared with 3% for those receiving placebo when combined with lifestyle interventions. Around one-third of participants treated with the drug achieved a weight loss of 20% or more.
Novo Nordisk said the safety and tolerability profile of oral semaglutide was consistent with the established injectable version. Adverse event-related discontinuation rates were 6.9% for oral semaglutide compared with 5.9% for placebo.
NVO Price Action: Novo Nordisk shares were up 2.52% at $50.30 at the time of publication on Wednesday, according to Benzinga Pro data.
Image Courtesy Novo Nordisk
Login to comment