FDA approves Wegovy HD, a 7.2 mg semaglutide dose, under priority voucher program

The FDA approved a higher 7.2 mg weekly dose of semaglutide (Wegovy HD) for weight loss and long-term maintenance in adults with obesity, or overweight with a weight-related condition, 54 days after filing under the Commissioner's National Priority Voucher pilot. In the 72-week STEP UP trial, people who stayed on treatment lost about 21% of body weight on 7.2 mg versus about 18% on 2.4 mg and 2% on placebo. Altered skin sensations (dysesthesia) were more common at the higher dose: 22% versus 6% on 2.4 mg.