European Commission Approves Novo Nordisk's Wegovy Pill For Chronic Weight Management Across The EU

Novo Nordisk has announced that the European Commission (EC) has approved Wegovy® pill, a once-daily oral formulation of semaglutide 25 mg, for the treatment of adults with obesity or overweight who have at least one weight-related health condition. The medication is approved for adults with a body mass index (BMI) of 30 kg/m² or higher, or a BMI of 27 kg/m² or higher with at least one obesity-related comorbidity. It is intended to be used alongside a reduced-calorie diet and increased physical activity.

The approval follows the positive recommendation issued by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) in May 2026 and marks a significant milestone in obesity treatment across Europe.

With this decision, Wegovy® pill becomes the first GLP-1 receptor agonist available in tablet form for chronic weight management across all European Union member states. It also represents the fifth regulatory approval for the oral formulation, following previous approvals in the United States, the United Kingdom, the United Arab Emirates, and Bahrain.

Mike Doustdar, President and Chief Executive Officer of Novo Nordisk, said the approval provides people living with obesity in Europe with another important treatment option. He noted that obesity is a serious chronic disease, and offering patients more choices can improve access to treatment and long-term adherence. According to Doustdar, many people may find taking a once-daily tablet more convenient and acceptable than injectable therapies, making it easier to begin and continue treatment. He added that the approval is not only an important regulatory achievement but also a step toward improving long-term health outcomes and addressing one of Europe's major public health challenges.

The European approval is supported by results from the comprehensive OASIS clinical trial program, including the Phase 3 OASIS 4 study. The trial evaluated the effectiveness and safety of once-daily oral semaglutide 25 mg in adults with obesity or overweight who also had at least one weight-related medical condition.

Results from the study showed that patients receiving oral semaglutide achieved an average weight loss of approximately 17% when combined with lifestyle changes, compared with around 3% for patients receiving placebo alongside the same lifestyle intervention. In addition, nearly one-third of participants treated with the medication achieved weight loss of 20% or more during the study, demonstrating substantial clinical benefit.

The safety findings were consistent with the well-established profile of injectable semaglutide, which has been used by patients for several years. Most side effects were manageable, and the proportion of patients who discontinued treatment because of adverse events was similar between the treatment and placebo groups, with discontinuation rates of 6.9% and 5.9%, respectively.

Alongside the approval of the oral formulation, the European Commission also approved a new 7.2 mg single-dose pen presentation of Wegovy® injection for adults living with obesity, providing another treatment option within the Wegovy® product portfolio.

Wegovy® pill is already commercially available in the United States, the United Kingdom, and the United Arab Emirates. Novo Nordisk said it plans to continue expanding global availability and expects to launch the oral therapy in additional countries during the second half of 2026 as part of its broader strategy to improve access to obesity treatment worldwide.