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FinanceNovo Nordisk's Wegovy oral weight-loss pill wins first EU approval
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The European Commission has approved Novo Nordisk's Wegovy pill, a once-daily oral semaglutide 25 mg treatment for adults with obesity (BMI ≥30) or overweight (BMI ≥27) with at least one weight-related comorbidity, to be used alongside diet and exercise. This marks the first oral GLP-1 receptor agonist approved for weight management across all EU member states. The decision follows a positive opinion from the EMA's CHMP in May 2026 and is supported by the OASIS 4 clinical trial, which showed approximately 17% weight loss in participants versus 3% for placebo. About one-third of treated patients achieved 20% or greater weight loss. The safety profile was consistent with the injectable version. This is the fifth regulatory approval for the Wegovy pill, following authorizations in the US, UK, UAE, and Bahrain. Novo Nordisk plans to introduce the treatment in additional countries during the second half of 2026.
Source report
Author: Vandana Singh Read time: 4 minutes
The European Commission has approved Novo Nordisk A/S' Wegovy pill, a once-daily oral semaglutide 25 mg treatment for adults with obesity or overweight who have at least one weight-related comorbidity.
This approval makes Wegovy the first GLP-1 receptor agonist available in tablet form for weight management across all European Union member states.
The treatment is indicated for adults with:
- A body mass index (BMI) of at least 30 kg/m², or
- A BMI of at least 27 kg/m² with one or more weight-related comorbidities
It is intended for use alongside a reduced-calorie diet and increased physical activity.
Regulatory Milestone
The decision follows a positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use in May 2026.
This marks the fifth regulatory approval for the Wegovy pill, following prior authorizations in:
- The United States
- The United Kingdom
- The United Arab Emirates
- Bahrain
The European Commission also approved the Wegovy 7.2 mg injection in a single-dose pen for obesity.
Novo Nordisk stated it plans to introduce the treatment in additional countries during the second half of 2026.
Clinical Trial Results
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.
Key findings include:
- Participants receiving oral semaglutide achieved approximately 17% weight loss, compared with 3% for those receiving placebo, when combined with lifestyle interventions
- Approximately one-third of participants treated with the drug achieved a weight loss of 20% or more
Safety Profile
Novo Nordisk reported that the safety and tolerability profile of oral semaglutide was consistent with the established injectable version.
- Adverse event-related discontinuation rates: 6.9% for oral semaglutide, compared with 5.9% for placebo
Image courtesy Novo Nordisk
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Novo Nordisk's Wegovy Pill Wins First European Approval for Oral Weight Loss Drug