- CHMP adopted a positive opinion recommending oral semaglutide (Wegovy pill, 25 mg) for EU weight-management approval, with SELECT data added for MACE risk reduction.
- OASIS4 (n=307) reported 16.6% mean weight loss with treatment adherence and ~33% of participants achieved >=20%; the OASIS programme enrolled ~1,300 adults.
- The label includes no drug-drug restrictions and a rollout is planned in select non-US markets in H2 2026.
Regulatory update
CHMP issued a positive opinion recommending marketing authorisation of once-daily oral semaglutide 25 mg (Wegovy pill) for reducing excess body weight and maintaining long-term weight reduction in the EU; SELECT data showing reduced major adverse cardiovascular events (MACE) are included in the recommended label.
Clinical efficacy
OASIS4 (307 adults, 64-week trial) reported a 16.6% mean weight loss under the trial product estimand (treatment-adherent); roughly one in three participants achieved ≥20% weight loss; the OASIS programme enrolled ~1,300 adults across four trials.
Safety and label details
Safety and tolerability were consistent with prior semaglutide trials; semaglutide is supported by >50 million patient‑years of real‑world safety data and the recommended label includes no drug–drug restrictions.
Regulatory and commercial status
Wegovy pill is already approved by the FDA for once‑daily use; injectable Wegovy formulations have broader regulatory approvals; the company plans launches in select non‑US markets in H2 2026.
