EU backs Novo Nordisk’s oral Wegovy for weight management

The positive opinion covers the use of Wegovy pill to reduce excess body weight and maintain long-term weight reduction in adults with obesity, or overweight with at least one weight-related comorbidity. According to Novo Nordisk, the opinion also includes data from the SELECT cardiovascular outcomes trial, showing that semaglutide reduces the risk of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction and non-fatal stroke.

If approved by the European Commission, Wegovy pill would become the first oral GLP-1 receptor agonist recommended for weight management in the EU. Current Wegovy treatment in Europe is administered as a once-weekly injection, with the active substance semaglutide acting through the GLP-1 pathway to regulate appetite, increase feelings of fullness and reduce hunger and cravings, according to the European Medicines Agency.

The CHMP recommendation is based on Novo Nordisk’s OASIS clinical programme. In the Phase IIIb OASIS 4 trial, oral semaglutide 25 mg achieved a mean body-weight reduction of 16.6% when treatment was adhered to, in adults with obesity or overweight and at least one comorbidity. One in three participants lost 20% or more of their body weight, according to the company.

For Novo Nordisk, the oral formulation could help defend its position in an increasingly competitive obesity market. Injectable Wegovy established semaglutide as one of the central drugs in the GLP-1 obesity category, but the field is moving quickly, with Eli Lilly advancing both injectable and oral competitors.

Convenience is likely to be a key commercial argument for oral Wegovy. Novo Nordisk said the pill has no drug–drug restrictions in the proposed label and plans to launch it in selected markets outside the US in the second half of 2026, pending approval. The company also pointed to early US demand, saying more than one million Americans began using Wegovy pill within four months of launch.

The European Commission usually follows CHMP recommendations, although the final marketing authorisation decision is still pending. If granted, the approval would add an oral option to Europe’s expanding GLP-1 obesity market at a time when drug developers are competing not only on weight-loss efficacy, but also on cardiovascular benefit, tolerability, dosing convenience and long-term patient adherence.