AI Analysis
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Novo Nordisk A/S announced US FDA approval of Wegovy HD (semaglutide 7.2 mg) for reducing excess body weight and maintaining weight reduction long-term, based on STEP UP trials showing 20.7% mean weight loss in obesity patients. The company expects US launch in April 2026, complementing existing Wegovy 2.4 mg.
Key Takeaways
1US FDA approved Wegovy HD (semaglutide 7.2 mg) on March 19, 2026
2STEP UP trial: 20.7% mean weight loss (efficacy estimand) in ~1,400 adults with obesity
3~31.2% of STEP UP patients achieved ≥25% weight loss
4STEP UP T2D trial: 14.1% mean weight loss in ~500 adults with obesity and type 2 diabetes
5Wegovy HD awarded Commissioner’s National Priority Voucher
6US launch expected in April 2026 in single-dose pen
7Wegovy 7.2 mg already approved for adults with obesity in EU and UK