Novo Nordisk wins EU authorisation for Wegovy pill and single‑dose 7.2 mg pen
- European Commission authorised once‑daily oral semaglutide 25 mg for adults with obesity (BMI ≥30) or overweight (BMI ≥27) with ≥1 weight‑related comorbidity, as adjunct to diet and exercise.
- OASIS 4 (64 weeks, 307 adults) showed ~17% mean weight loss with oral semaglutide 25 mg versus 3% with placebo; ~1 in 3 achieved ≥20% weight loss.
- Safety profile for the pill was consistent with injectable semaglutide; adverse‑event discontinuations were 6.9% vs 5.9% for placebo.
- EC also authorised a single‑dose Wegovy 7.2 mg injection pen; the pill is already authorised in the US, UK, UAE and Bahrain and further country launches are planned in H2 2026.
Regulatory decision
The European Commission granted marketing authorisation for a once‑daily oral semaglutide 25 mg tablet for weight management in adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 kg/m²) with at least one weight‑related comorbidity, to be used alongside a reduced‑calorie diet and increased physical activity. The EC also authorised a single‑dose Wegovy 7.2 mg injection pen. The approval follows a positive CHMP opinion issued in May 2026 and represents the first GLP‑1 receptor agonist pill authorised across EU member states; it is the product's fifth regulatory approval after the US, UK, UAE and Bahrain.
Clinical evidence
The decision is based on the OASIS phase 3 programme, notably OASIS 4, a 64‑week phase 3b trial of once‑daily oral semaglutide 25 mg versus placebo in 307 adults with obesity or overweight and comorbidities. Using the trial product estimand, oral semaglutide 25 mg produced approximately 17% mean weight loss versus 3% with placebo when combined with lifestyle intervention, and about one in three participants achieved 20% weight loss or more.
Safety and availability
Reported safety and tolerability for the oral formulation were consistent with the established injectable semaglutide profile, with adverse‑event–related discontinuations nearly comparable to placebo (6.9% vs 5.9%). The pill is already available in the US, UK and UAE, and the company has committed to launching it in additional countries in the second half of 2026.
Source: Novo Nordisk
