Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has adopted a positive opinion, recom-mending marketing authorisation of Wegovy® pill (once-daily oral semaglutide 25 mg) to re-duce excess body weight and maintain long-term weight reduction. The positive opinion also includes SELECT data in the label, demonstrating that Wegovy® reduces the risk of major ad-verse cardiovascular events (MACE)*.
Wegovy® pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy recom-mended for approval by CHMP for weight management in the EU. The recommendation is based on the OASIS trial programme and the SELECT[2] trial. In the OASIS 4 trial, oral semag-lutide 25 mg taken once daily demonstrated 16.6% mean weight loss when treatment was ad-hered to in adult participants with obesity or overweight with one or more comorbidities1. The weight loss achieved with Wegovy® pill is similar to that of injectable Wegovy® 2.4 mg. Fur-thermore, one in three people experienced 20% or greater weight loss in the OASIS 4 trial1.
The well-known safety and tolerability profile of semaglutide was reaffirmed with Wegovy® pill in the OASIS 4 trial, which was comparable to previous semaglutide trials for weight manage-ment. Semaglutide is supported by more than 50 million patient-years of real-world safety data, and notably, the Wegovy® pill label includes no drug–drug restrictions with concomitant medi-cations.
“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 mar-kets outside the US in the second half of 2026.”
Source: Riyadh Daily