The U.S. Food and Drug Administration today announced six additional awardees under the Commissioner’s National Priority Voucher (CNPV) pilot program. This second cohort brings the total number of voucher recipients to 15, underscoring the agency's commitment to accelerating the review of products with the potential to address key national priorities.

“National priority vouchers are granted to a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We are pioneering new ways of bringing these cures and meaningful treatments to the market faster.”

Upon submission of a complete application, national priority voucher holders will receive a decision within months, a drastic reduction of the typical review timeline. The faster timeframe is contingent upon additional requirements from the company, and FDA staff reserve the right to extend the review as needed.

The cornerstone of the accelerated timeline is a one-day “tumor board style” meeting which convenes a multidisciplinary group of physicians and scientists for a team-based review. Under the Federal Food, Drug, and Cosmetic Act; the 21st Century Cures Act; and the Food and Drug Administration Safety and Innovation Act, the FDA is authorized to test innovative regulatory approaches to accelerate review, foster public health preparedness, and improve access to safe, effective, and affordable therapies.

The following products were selected following external applications and internal nominations from FDA review divisions:

• Zongertinib for HER2 lung cancer
• Bedaquiline for drug-resistant tuberculosis in young children
• Dostarlimab for rectal cancer
• Casgevy for sickle cell disease
• Orforglipron for obesity and related health conditions  
• Wegovy for obesity and related health conditions

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