EU Commission approves Novo Nordisk's oral weight‑loss pill

The European Commission has authorized the market launch of Novo Nordisk's 25 mg oral semaglutide tablet, the first oral therapy for weight management approved in Europe. The drug is indicated for adults with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) who have at least one weight‑related comorbidity. Approval follows a positive opinion from the EMA’s Committee for Human Medicinal Products and is based on the OASIS 4 trial, which showed an average 17 % body‑weight reduction after 64 weeks of treatment, compared with 2.7 % for placebo. One‑third of participants were early responders, achieving about a 22 % loss. Data from the SELECT study were also included, demonstrating a 20 % reduction in major adverse cardiovascular events for patients with overweight or obesity. Professor Paolo Sbraccia of Tor Vergata University in Rome said the pill meets a clear need for patients seeking a convenient, effective weight‑loss option.

The approval expands therapeutic options for obesity management in the EU, offering a non‑injectable alternative that may improve adherence and outcomes for millions of adults across member states.