European Medicines Agency Backs Oral Wegovy as First GLP-1 Pill for Weight Management in the EU

Europe’s top drug regulator has moved closer to approving a daily weight-loss pill. The Committee for Medicinal Products for Human Use (CHMP), operating under the European Medicines Agency (EMA), issued a positive opinion for once-daily oral semaglutide 25 mg, sold as the Wegovy pill. The recommendation covers long-term weight reduction in adults. It also includes cardiovascular outcomes data from the SELECT trial, showing Wegovy reduces the risk of major adverse cardiovascular events (MACE). 

Wegovy pill produced a mean weight loss of 16.6% in clinical trials. That result places it ahead of other oral treatments in its class. The OASIS phase 3 program supported the submission, enrolling roughly 1,300 adults with obesity or overweight plus at least one related health condition. Notably, the proposed label carries no drug-drug restrictions, making it easier to prescribe alongside other medications. 

Semaglutide works by mimicking a natural gut hormone called GLP-1. It reduces appetite, slows digestion, and helps control blood sugar. The pill version uses a carrier molecule to help the drug absorb through the stomach lining. This sets it apart from older weight-loss drugs and makes it the first peptide-based obesity pill of its kind. The CHMP opinion covers adults with obesity or overweight who have at least one weight-related health problem. 

The EMA recommendation follows U.S. approval of the oral form in December 2025. Weekly prescriptions in the United States have climbed above 200,000. More than one million Americans started using the Wegovy pill within just four months of its launch. Those numbers show strong patient interest in a pill-based option. Many people prefer tablets over injections, and that preference is driving rapid uptake. 

Novo Nordisk now faces growing competition, with Eli Lilly pushing forward both injectable and oral rivals in the obesity space. The CHMP also backed Wegovy 7.2 mg injectable on the same day, with STEP UP trial data showing a mean weight loss of 20.7%. Together, these two approvals significantly expand Novo Nordisk’s semaglutide lineup. The company plans to launch the Wegovy pill in select markets outside the U.S. in the second half of 2026. 

An oral GLP-1 pill could reach patients who struggle with injections. Obesity is linked to serious conditions, including heart disease, type 2 diabetes, and joint problems. The SELECT trial data in the label confirm that semaglutide cuts the risk of cardiovascular death, non-fatal heart attack, and non-fatal stroke. The European Commission still holds final approval authority. It typically follows CHMP recommendations, so a green light appears likely. Doctors and insurers will watch closely as pricing and prescribing details become clear.