Key Highlights
- European Medicines Agency experts have endorsed Novo Nordisk’s tablet form of Wegovy for market approval
- The medication represents Europe’s inaugural oral weight-loss treatment to secure regulatory committee backing
- Clinical trial participants achieved 16.6% average weight reduction over 64 weeks compared to 2.7% with placebo
- Final approval from the European Commission remains pending
- Novo introduced the tablet version in America this year; competitor Eli Lilly released Foundayo in April
European drug regulators have given their backing to Novo Nordisk’s tablet version of Wegovy, paving the way for what could become the continent’s first approved oral obesity medication.
The positive opinion arrived from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on Friday, May 22. This endorsement represents an expansion of Wegovy’s current European license, which presently covers solely the once-weekly injection formulation.
The European Commission now faces the task of evaluating the CHMP’s guidance before delivering a definitive verdict on commercial authorization.
NVO stock hovered around $65 in New York trading when the news broke, although shares have encountered headwinds throughout the year due to general market volatility and competitive dynamics.
The tablet formulation utilizes semaglutide — the identical active compound found in Novo’s injected versions of Wegovy and Ozempic. The pharmaceutical giant previously commercialized an oral semaglutide medication for diabetes management branded as Rybelsus.
The EMA’s favorable assessment draws from evidence compiled during advanced clinical testing. Study participants receiving the 25mg oral Wegovy formulation experienced an average 16.6% reduction in body weight across 64 weeks. Those receiving placebo lost merely 2.7%.
According to the EMA, the tablet form “provides an oral option to weekly injections administered under the skin that may prove more suitable for certain patients.” The treatment is intended for use with dietary modifications and exercise in adults with obesity or excess weight who have at least one weight-associated health condition.
Competition Between Novo and Lilly in Oral Formulations
Novo established its US market presence first. The pharmaceutical company rolled out its Wegovy tablet in America following FDA clearance in December 2024, ahead of Eli Lilly’s daily weight-loss pill Foundayo, which debuted stateside in April 2026.
Across the Atlantic, Novo appears poised to claim first-mover status once more. Lilly’s oral obesity treatment has yet to receive backing from EMA reviewers.
Preliminary American prescription figures for both tablet products have proven robust, lending credence to the theory that oral alternatives broaden the total addressable market rather than merely shifting patients from injectable therapies.
Industry analysts project the obesity pharmaceutical sector will reach $150 billion in annual revenue over the coming decade. Both Novo and Lilly are competing aggressively to establish dominant positions through oral medication offerings.
Regulatory Timeline Ahead
The CHMP’s positive opinion advances to the European Commission, which holds authority to grant formal commercial authorization. That regulatory sequence is anticipated to wrap up during the summer months, per EMA executive director Emer Cooke, who discussed the timeline with Reuters last month.
Following Commission approval, the oral Wegovy tablet will become available for physician prescription throughout EU nations. Novo already maintains established distribution networks via its current injectable Wegovy presence across Europe.
The oral Wegovy formulation requires once-daily administration. The EMA’s recommendation pertains specifically to the 25mg dosage evaluated in the definitive clinical study.
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