European Commission approves oral semaglutide pill for obesity treatment

The European Commission has authorized the marketing of a 25 mg oral tablet of semaglutide, making it the first oral GLP‑1 receptor agonist approved in the EU for managing obesity and overweight in adults. The drug, developed by Novo Nordisk, is taken once daily on an empty stomach, with a minimum eight‑hour fast before dosing and a 30‑minute wait before eating, drinking, or taking other medicines. It is indicated for adults with a BMI of 30 kg/m² or higher, or a BMI of 27 kg/m² with weight‑related comorbidities such as type‑2 diabetes, hypertension, or dyslipidaemia.

Clinical trial Oasis 4 showed an average weight loss of 17 % after 64 weeks of treatment, with about one in three early responders achieving roughly 22 % loss. The safety profile mirrors that of other GLP‑1 drugs, with mainly gastrointestinal side‑effects that tend to lessen over time. The approval also considers cardiovascular benefits demonstrated in the SELECT study of the injectable formulation, which showed a 20 % reduction in major adverse cardiovascular events. While the oral option removes the need for weekly injections, regulators stress that it must be combined with a reduced‑calorie diet and increased physical activity.