Wegovy pill (oral semaglutide) recommended by CHMP for approval in the EU as the first oral GLP-1 representing the most efficacious oral obesity treatment in its class

(MENAFN- Global Advertising) 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, recommending mar-keting authorisation of Wegovy® pill (once-daily oral semaglutide 25 mg) to reduce 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 adverse cardiovascular events (MACE).

Wegovy® pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist therapy recommended for approval by CHMP for weight management in the EU. The recommendation is based on the OA-SIS trial programme and the SELECT[2] 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 comorbidities1. The weight loss achieved with We-govy® pill is similar to that of injectable Wegovy® 2.4 mg. Furthermore, one in three people experi-enced 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 management. Semag-lutide 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 medications.

“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.”

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