Novo Nordisk: Wegovy pill approved in UK as first daily GLP-1 weight-loss tablet in Europe

Regulatory decision and indication

The UK Medicines and Healthcare products Regulatory Agency (MHRA) approved Wegovy pill (semaglutide tablets) as a once‑daily GLP‑1 receptor agonist for adults with obesity (BMI ≥30 kg/m²) or overweight (BMI ≥27 to <30 kg/m²) with at least one weight‑related condition, to be used in addition to a reduced‑calorie diet and increased physical activity.

Clinical evidence from OASIS 4

Approval was based on the phase 3 OASIS 4 trial in 307 adults without type 2 diabetes randomised 2:1 to semaglutide 25 mg or placebo once daily for 64 weeks plus lifestyle interventions. In the treatment‑policy (regardless of adherence) analysis, semaglutide achieved mean weight loss of 13.6% versus 2.4% with placebo at week 64; the on‑treatment analysis showed 16.6% versus 2.7% respectively. Co‑primary endpoints included percent change in body weight and proportion achieving ≥5% weight loss at week 64.

Safety, availability and context

The most common adverse events were gastrointestinal (nausea, vomiting, diarrhoea), reported in 74.0% of participants on semaglutide versus 42.2% on placebo; adverse events led to treatment discontinuation in ~6.9% of the semaglutide group. Novo Nordisk expects Wegovy pill to be available via private prescription in the UK within weeks; the MHRA is the third regulator to approve the medicine after the US FDA and the UAE authority.