Wegovy® pill demonstrates best-in-class efficacy with a mean weight loss of 16.6% and becomes the first oral GLP-1 treatment recommended by CHMP for weight management in the European Union.
The recommendation includes landmark SELECT trial data showing a reduced risk of major adverse cardiovascular events (MACE).
Wegovy® pill is the only oral GLP-1 treatment with no drug-drug restrictions in its label.
Novo Nordisk plans to launch Wegovy® pill in select markets outside the U.S. in the second half of 2026.
BAGSVAERD, DENMARK – Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for the Wegovy® pill (once-daily oral semaglutide 25 mg). The treatment is recommended to reduce excess body weight and maintain long-term weight reduction in adults.
Significantly, the positive opinion includes data from the landmark SELECT cardiovascular outcomes trial in the label, demonstrating that Wegovy® reduces the risk of major adverse cardiovascular events (MACE).
The Wegovy® pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy recommended for approval by the CHMP for weight management in the EU. The recommendation is backed by robust data from the OASIS clinical trial programme and the SELECT trial.
In the OASIS 4 trial, adult participants with obesity or overweight and at least one comorbidity who adhered to the once-daily 25 mg oral semaglutide treatment achieved a 16.6% mean weight loss. This level of efficacy is comparable to that of the injectable version of Wegovy® (2.4 mg). Furthermore, an impressive one in three participants in the OASIS 4 trial experienced a weight loss of 20% or greater.
The clinical trials reaffirmed the well-known safety and tolerability profile of semaglutide, with results for the Wegovy® pill aligning with previous semaglutide weight management trials. Semaglutide’s safety profile is supported by more than 50 million patient-years of real-world data. Notably, the Wegovy® pill label carries no drug-drug interaction restrictions with concomitant medications, offering high flexibility for patients.
“We are encouraged by CHMP’s positive opinion for Wegovy® pill, bringing the most efficacious oral GLP-1 in its class one step closer to becoming the first approved oral treatment in its class for weight management in the EU,” said Mike Doustdar, president and CEO of Novo Nordisk. “The demand for effective and convenient obesity treatment is already evident in the U.S., where more than 1 million Americans began using Wegovy® pill within the first four months following launch. We look forward to bringing this innovative medicine to the first markets outside the US in the second half of 2026.”
About Wegovy® Pill
Wegovy® pill (oral semaglutide 25 mg) is an oral glucagon-like peptide-1 (GLP-1) receptor agonist taken once daily. It is designed to mimic the naturally occurring hormone GLP-1, which regulates appetite and food intake.
