Novo Nordisk (NYSE: NVO) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for Wegovy pill, a once-daily oral semaglutide 25 mg treatment for weight management.

The committee's recommendation covers reducing excess body weight and maintaining long-term weight reduction. The positive opinion includes SELECT data demonstrating that Wegovy reduces the risk of major adverse cardiovascular events.

Wegovy pill would become the first oral glucagon-like peptide-1 receptor agonist therapy approved for weight management in the European Union if final authorization is granted. The recommendation is based on the OASIS trial program and the SELECT2 trial.

In the OASIS 4 trial, oral semaglutide 25 mg taken once daily demonstrated 16.6% mean weight loss when treatment was adhered to in adult participants with obesity or overweight with one or more comorbidities. The company stated the weight loss achieved with Wegovy pill is similar to that of injectable Wegovy 2.4 mg. One in three people experienced 20% or greater weight loss in the OASIS 4 trial.

The safety and tolerability profile of semaglutide was reaffirmed with Wegovy pill in the OASIS 4 trial. Semaglutide is supported by more than 50 million patient-years of real-world safety data. The Wegovy pill label includes no drug-drug restrictions with concomitant medications.

Novo Nordisk reported that more than 1 million Americans began using Wegovy pill within the first four months following its U.S. launch. The company expects to bring the treatment to markets outside the United States in the second half of 2026.