Key Highlights
- European Medicines Agency (EMA) has endorsed Novo Nordisk’s oral version of Wegovy for regulatory approval
- Represents Europe’s first oral obesity treatment to achieve positive EMA assessment
- Clinical trials demonstrated 16.6% average weight reduction compared to 2.7% with placebo
- Final marketing clearance awaits European Commission decision
- Novo introduced its Wegovy tablet in America earlier this year; Eli Lilly released Foundayo pill in April
European regulators have given a positive assessment to Novo Nordisk’s tablet formulation of Wegovy, positioning the treatment to become Europe’s inaugural approved oral weight-management medication.
The endorsement emerged from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on Friday, May 22. This recommendation expands Wegovy’s current European approval, which presently encompasses only the once-weekly injection.
The European Commission will now evaluate the CHMP’s positive opinion before rendering a final marketing authorization verdict.
NVO stock was hovering near $65 in New York trading when the news broke, although shares have experienced headwinds this year due to wider market volatility and competitive pressures.
The tablet formulation contains semaglutide — identical to the active compound found in Novo’s injectable Wegovy and Ozempic products. The pharmaceutical giant currently markets an oral semaglutide medication for type 2 diabetes management called Rybelsus.
The EMA’s positive recommendation stems from late-stage trial results. Participants receiving the 25mg oral Wegovy experienced average body weight reductions of 16.6% across 64 weeks. Control group participants lost merely 2.7%.
According to the EMA, the tablet formulation “offers an oral alternative to weekly subcutaneous injections that may be more convenient for some patients.” The treatment is intended for use with dietary modifications and exercise in obese or overweight adults who have at least one weight-related health condition.
Competition Between Novo and Lilly in the Oral Segment
Novo secured first-mover status in America. The pharmaceutical company launched its Wegovy tablet domestically following FDA clearance in December 2024, ahead of Eli Lilly’s daily weight-loss pill Foundayo which debuted in the US in April 2026.
Across the Atlantic, Novo appears positioned to capture early momentum once more. Lilly’s oral obesity medication has yet to receive positive assessment from European regulators.
Preliminary American prescription trends for both tablets have been robust, reinforcing theories that oral formulations broaden the total addressable market rather than simply cannibalizing injectable sales.
Industry analysts project the global obesity pharmaceutical market will reach $150 billion in annual revenue within ten years. Both Novo and Lilly are competing intensely to establish dominance in this space through oral medication alternatives.
Regulatory Timeline and Market Entry
The CHMP’s recommendation advances to the European Commission, which will render the official marketing authorization ruling. Based on comments EMA head Emer Cooke made to Reuters last month, this process should conclude during the summer months.
Following Commission approval, the oral Wegovy formulation will become available for prescription throughout EU member nations. Novo has established commercial distribution networks through its existing injectable Wegovy presence across Europe.
The oral Wegovy tablet requires once-daily administration. The EMA’s endorsement covers the 25mg dosage strength utilized in the pivotal clinical study.
