Tuesday, 02 January 2024 12:17 GMT

Wegovy®️ Pill Recommended By CHMP For Approval In The EU


(MENAFN- Asdaf News) Riyadh – Asdaf News: With a mean weight loss of 16.6%[1], Wegovy®️ pill demonstrates best-in-class weight-loss efficacy and is the first oral GLP 1 treatment recommended by CHMP for weight management in the EU. CHMP recommends Wegovy®️ pill for approval to reduce excess body weight and maintain long-term weight reduction. The recommendation also includes data from SELECT which demonstrates that Wegovy®️ reduces the risk of major adverse cardiovascular events (MACE)*, in the label Wegovy®️ pill is the only oral GLP-1 treatment with no drug-drug restrictions in the label Novo Nordisk plans to launch Wegovy®️ pill in select markets outside the US in the second half of 2026 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 marketing 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 OASIS 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 Wegovy®️ pill is similar to that of injectable Wegovy®️ 2.4 mg. Furthermore, 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 management. 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 medications

MENAFN07062026007116015312ID1111223032



Asdaf News

Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.

Search