FDA Approves Novo Nordisk's Higher-Dose Wegovy HD Under National Priority Voucher Program
U.S. regulators on Thursday granted approval for the fourth product in their national priority vaccine and drug voucher program, specifically a new 7.2-mg high-dose version of semaglutide known as Wegovy HD by Novo Nordisk.
Key Points
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1The FDA has granted accelerated 74-day review approval for the higher-dose (7.2 mg) version of Wegovy, known as HD.
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2Novo Nordisk plans to launch this stronger injectable dose in April through pharmacies and clinics across the U.S.,
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3This new dosage was approved under a pilot National Priority Voucher program designed by FDA Commissioner Dr. Robert Califf.
Developments
Perspectives
The FDA has granted accelerated approval for the 7.2-milligram dose of Wegovy through an expedited pilot review process, marking it as one of four products to receive clearance under this new program.
— (FDA)Novo Nordisk secured a significant regulatory victory by having its higher-dose weight-loss drug approved via the Commissioner's National Priority Voucher programme designed for accelerating approvals in an increasingly pressured obesity market.
— (Thehindubusinessline, Fiercepharma)Novo Nordisk announced that the US FDA has approved a higher (7.2 mg) dose for its weight-loss drug Wegovy under an accelerated voucher program following positive trial results showing greater average bodyweight loss compared to lower doses amid intense market competition and price pressures from President Donald Trump's administration plans, with expectations of launching this new single-dose pen in April 2026 at a yet-to-be-announced price.
The FDA has approved Novo Nordisk Wegovy in an accelerated review process after 54 days for its new higher-dose version (7.2 mg), which is scheduled to be available at U.S. pharmacies starting this April and demonstrated a greater weight loss of about 19% compared to the previous maximum dose's ~16%.
The FDA approved Novo Nordisk's Wegovy HD, featuring a new high-dose formulation (7.2 mg) for adults with obesity who have tolerated lower doses and require further weight reduction; this approval was granted under the National Priority Voucher program following positive results from its Step Up trial showing an average 20.7% body-weight loss over seven weeks in adhering patients, compared to a previous high dose of only about half that efficacy (14-35%).