Overview
- Britain’s medicines regulator licensed the once‑daily semaglutide tablet for adults with a BMI of 30 or higher and for those with a BMI of 27–29.9 who have a weight‑related condition.
- The decision drew on OASIS‑4 phase 3 data showing about 16.6–17% mean weight loss among participants who stayed on treatment and about 13.6–14% in analyses regardless of adherence after 64 weeks versus roughly 2–3% for placebo.
- The tablet requires stepwise dose escalation from 1.5mg to 4mg, 9mg and 25mg, must be swallowed whole after at least eight hours fasting and users must wait 30 minutes before eating or taking other medicines because food alters absorption.
- The approval allows private access within weeks, but NHS availability is not authorised until Novo Nordisk submits evidence and NICE completes a cost‑effectiveness appraisal, and private demand has already produced large waitlists on digital providers.
- Novo Nordisk plans commercial rollouts later this year and faces close competition from rival oral GLP‑1s; the company also disclosed on the day of approval that it is investigating a cyber‑attack that affected some non‑public data.