European Medicines Agency Backs Novo Nordisk's Oral Wegovy Tablets
On May 22, 2026, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended extending the marketing authorization of Wegovy (semaglutide) to include an oral tablet formulation for weight management. This represents Europe's first oral GLP-1 receptor agonist recommended specifically for chronic weight management.
Unlike Eli Lilly's recently approved oral small-molecule Eli Lilly's Foundayo (Orforglipron) Secures FDA Approval and Launches into Fierce Oral GLP-1 Battle, which has no dietary limitations, oral Wegovy is a peptide-based formulation that carries strict administration requirements to ensure adequate gastrointestinal absorption.
Administration Restrictions
The tablet must be taken once daily on an empty stomach after fasting for at least 8 hours. Patients must wait at least 30 minutes before eating, drinking, or taking any other oral medications. These strict requirements present a potential commercial disadvantage compared to Lilly's food-flexible oral alternative.
Clinical Efficacy and Safety
- Efficacy: In a Phase 3 clinical trial involving 307 adults over 64 weeks, patients taking Wegovy tablets achieved an average body weight reduction of 13.61%, compared with 2.18% in the placebo group.
- Responders: Approximately 76.3% of individuals on oral Wegovy achieved a weight loss of 5% or more, compared to 30.5% on placebo.
- Tolerability: The safety profile is consistent with weekly subcutaneous Wegovy injections. The most common adverse events were gastrointestinal (nausea, diarrhea, constipation, vomiting), occurring primarily at the start of treatment.
Financial Context
Novo Nordisk (NYSE: NVO) continues to expand its cardiometabolic portfolio to counter Lilly's rapid growth. According to Novo Nordisk's financial metrics, the company generated $327.80 billion (DKK equivalent) in TTM revenue with an 83.2% gross margin. While NVO's latest quarterly EPS of $6.63 slightly missed analyst expectations of $6.96, the company is actively advancing its next-generation obesity pipeline, including testing its combination therapy CagriSema in Phase 3 trials and executing a DKK 15 billion share buyback program.