FDA approves Wegovy HD (7.2 mg) with 20.7% mean weight loss

The US FDA approved Wegovy HD, a once-weekly 7.2 mg semaglutide injection, to reduce excess body weight and maintain the loss long term. In the STEP UP trial, patients lost 20.7% of body weight on average on the efficacy measure. Novo said it expected a US launch in a single-dose pen in April 2026 and did not disclose a price.

• 20.7% mean weight loss at 72 weeks (efficacy estimand)
• 18.7% on the treatment-regimen estimand
• 31.2% of patients lost 25% or more of body weight
• US single-dose pen launch expected April 2026