Overview
- The CHMP issued a positive opinion recommending approval of semaglutide 7.2 mg, moving the application to the European Commission.
- In 72‑week STEP UP trials, adults without diabetes lost an average of 20.7% of body weight, and about one in three reached at least 25% loss.
- Investigators reported that 84% of weight lost came from fat mass and that muscle function was preserved.
- Safety and tolerability at 7.2 mg were described as consistent with the already approved 2.4 mg dose.
- Novo Nordisk applied for a single‑dose 7.2 mg device and said the dose is under review in the US and UK, with an FDA filing submitted in November under an expedited voucher program and potential EU availability early next year pending approval.