Novo Nordisk has secured European Commission approval for its once-daily Wegovy pill, giving the Danish drugmaker a major boost in the fast-growing obesity-treatment market. The approval makes it the first oral GLP-1 weight-loss treatment cleared in the European Union for adults with obesity or overweight who also have at least one weight-related health condition.
The approval follows a positive recommendation from the European Medicines Agency in May and strengthens Novo’s position in the race to develop convenient alternatives to injectable obesity drugs. The pill is intended to be used alongside diet and exercise, and the company said the decision was based on clinical trial data showing average weight loss of about 17% compared with about 3% for placebo.
The approval also covers Wegovy 7.2 mg in a single-dose pen. Novo said the safety profile of the pill was consistent with injectable semaglutide, and treatment discontinuations linked to side effects were 6.9% for the pill and 5.9% for placebo.
“Today’s European Commission approval of Wegovy as a once-daily pill brings another important treatment option to people living with obesity,” said Novo Nordisk Chief Executive Mike Doustdar. He added that a tablet may be simpler and more acceptable for some patients than injections.
The European approval gives Novo a head start over rival Eli Lilly, which is also pursuing an oral obesity treatment in Europe. It marks another step in the company’s effort to expand Wegovy beyond injections and broaden access to obesity care across major markets.