Novo Nordisk’s Wegovy pill recommended for EU Approval
The European Medicines Agency has recommended extending the marketing authorisation for Wegovy to include a once-daily pill
EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the Wegovy pill. Already approved in the US, the pill has seen huge uptake, with more than 1 million people using it within the first 4 months of its launch.
Developed by Novo Nordisk, it is intended for adults living with obesity, or those who are overweight and have at least one weight-related comorbidity, such as cardiovascular disease, hypertension, or type 2 diabetes.
The new oral formulation could broaden access for patients reluctant to use injections. Unlike some competing oral therapies, Wegovy pill also carries no drug-drug restrictions in its proposed label where one medicine can react with another producing harmful side effects.
“We are encouraged by CHMP’s positive opinion for Wegovy pill,” said Novo Nordisk CEO, Mike Doustdar. “The demand for effective and convenient obesity treatment is already evident in the US. We look forward to bringing this innovative medicine to the first markets outside the US in the second half of 2026.”
The CHMP recommendation is based on clinical trials showing that participants taking oral semaglutide achieved an average weight loss of 16.6% when treatment was adhered to, with one in three participants losing at least 20% of their body weight. According to Novo Nordisk, the pill's efficacy was comparable to that of the once-weekly injectable Wegovy 2.4 mg formulation, already approved in Europe and other major markets.
Novo Nordisk said it expects to launch Wegovy pill in selected markets outside the United States in the second half of 2026, pending final approval by the European Commission.