Novo Nordisk's oral Wegovy pill cleared by EU regulators

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Novo Nordisk’s oral semaglutide tablet, Wegovy® 25 mg. The recommendation makes the pill the first oral GLP‑1 medication approved in the EU for the management of obesity, offering a daily tablet alternative to the existing weekly injections.

Phase 3 OASIS 4 trial data showed an average weight loss of 16.6 % among adults who adhered to the regimen, with efficacy comparable to the injectable Wegovy® and one‑third of participants losing 20 % or more of their initial body weight. Cardiovascular outcome data from the SELECT study were also included, indicating a reduction in major adverse cardiac events. Safety data revealed no new concerns.

The positive CHMP opinion is now pending final endorsement by the European Commission. Novo Nordisk plans to launch the oral product in selected European markets in the second half of 2026, potentially including Romania. Over one million patients in the United States have already been treated with the oral formulation since its FDA approval. The market is competitive, with Eli Lilly’s oral GLP‑1 drug Foundayo also under EMA review.