EMA recommends Novo Nordisk’s Wegovy pill for obesity

Edited by Robert McTiernan··3 min read

Novo Nordisk’s Wegovy pill (oral semaglutide 25 mg) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, recommending marketing authorisation for weight management in adults with obesity or overweight and at least one weight-related comorbidity. The recommendation positions the once-daily tablet as the first oral GLP-1 receptor agonist to clear this regulatory threshold in the EU.

The CHMP opinion covers reduction of excess body weight and maintenance of long-term weight reduction. The recommended label also incorporates cardiovascular outcomes data from the SELECT trial, reflecting a reduction in the risk of major adverse cardiovascular events including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. Notably, the label carries no drug-drug restrictions, meaning no limitations on concomitant medications are specified — a feature Novo Nordisk has highlighted as a clinical differentiator. A final European Commission decision, which typically follows a positive CHMP opinion, is required before formal EMA marketing authorisation is granted.

The recommendation is supported by the OASIS trial programme, a Phase III development programme evaluating once-daily oral semaglutide at doses of 25 mg and 50 mg in approximately 1,300 adults with obesity or overweight. The pivotal basis for the weight management indication is OASIS 4, a 64-week Phase IIIb trial comparing oral semaglutide 25 mg once daily against placebo in 307 adults. The primary measure of efficacy was weight loss at trial end. Based on the trial product estimand — reflecting outcomes if all participants adhered to treatment — mean weight loss reached 16.6%, with one in three participants achieving 20% or greater reduction. The safety and tolerability profile was consistent with prior semaglutide trials. The SELECT cardiovascular outcomes trial data, previously used to support the injectable Wegovy label, were incorporated into the CHMP recommendation for the oral formulation.

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Semaglutide is a GLP-1 receptor agonist that mimics the endogenous incretin hormone GLP-1, activating receptors in the gut, pancreas, and central nervous system to reduce appetite and food intake. The oral formulation relies on co-administration with the absorption enhancer SNAC (sodium N-[8-(2-hydroxybenzoyl)amino]caprylate), which facilitates gastric absorption of the peptide and enables meaningful systemic exposure from an oral dose — a longstanding challenge for peptide-based therapeutics. The 25 mg once-daily dose achieves weight loss comparable to that of injectable Wegovy 2.4 mg, according to Novo Nordisk’s cross-trial comparisons.

The oral GLP-1 obesity treatment field is currently defined by injectable agents, with Eli Lilly’s Zepbound (tirzepatide), a dual GIP and GLP-1 receptor agonist, representing the primary approved competitor in both the US and EU markets. Tirzepatide received EMA marketing authorisation for weight management in mid-2024 under the brand name Mounjaro. The oral semaglutide CHMP recommendation, if converted to full authorisation, would introduce the first approved oral option in this class in the EU. Novo Nordisk said it plans to launch the tablet in select markets outside the US in the second half of 2026, having already received FDA approval for the formulation in December 2025.

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