FDA approves Wegovy HD, a higher-dose weight-loss option under a national priority program
TL;DR Summary
The FDA cleared Wegovy HD (7.2 mg) for weight loss and long-term maintenance in adults with obesity or overweight plus a weight-related condition, marking the fourth approval under the Commissioner’s National Priority Voucher program. The higher dose yielded greater average weight loss with a safety profile consistent with prior semaglutide doses, though GI side effects were common and there is a boxed warning for thyroid C-cell tumors; the approval was granted to Novo Nordisk, and a June public hearing on the voucher program is planned.
- FDA Approves Fourth Product Under National Priority Voucher Program, Higher Dose Semaglutide fda.gov
- Weight-loss treatment is on the verge of a dramatic shift – again CNN
- FDA approves higher dose version of weight loss drug Wegovy as Novo Nordisk tries to win back market share CNBC
- FDA approves new higher-dose version of Wegovy shots The Boston Globe
- Novo’s Wegovy HD passes muster under FDA national priority voucher program Fierce Pharma
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