Novo Nordisk Wegovy® Pill Recommendation for EU Approval

Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorisation for Wegovy® pill (once-daily oral semaglutide 25 mg) in the EU for weight reduction and long-term weight maintenance. The recommendation, based on the OASIS trial programme and SELECT data, includes evidence that Wegovy® reduces the risk of major adverse cardiovascular events (MACE). This marks the first oral GLP-1 treatment recommended by CHMP for weight management in the EU. The OASIS 4 trial showed a mean weight loss of 16.6% with oral semaglutide, comparable to injectable Wegovy®. The drug has a well-established safety profile and no drug-drug restrictions. Novo Nordisk plans to launch Wegovy® pill in select markets outside the US in the second half of 2026.