FDA - Food and Drug Administration
12/19/2025 | Press release | Distributed by Public on 12/19/2025 14:46
December 19, 2025 - FDA Grants Two National Priority Vouchers
For Immediate Release: December 19, 2025
The U.S. Food and Drug Administration today awarded national priority vouchers under the Commissioner's National Priority Voucher (CNPV) pilot program to two investigational products for their potential to increase access through affordability for American patients.
The products are:
- Enlicitide decanoate - an oral PCSK9 inhibitor for lowering LDL cholesterol
- Sacituzumab Tirumotecan - a trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate
"High health care costs and prescription drug prices threaten to undermine all the technological advancements we see in the medical field," said FDA Commissioner Marty Makary, M.D., M.P.H. "We're pleased to grant these vouchers to two products that may significantly contribute to our goal of improving the accessibility and affordability of healthcare in America."
With these awards,18 products have now received a voucher under the CNPV pilot program since it was established in June 2025. On December 9, the agency announced its first review decision under the program, achieving significant time savings compared to a typical review timeline.
About CNPV
The CNPV pilot program is designed to accelerate the review of products with the potential to address one or more of the following key national priorities: addressing a U.S. public health crisis, delivering more innovative cures for the American people, addressing a large unmet medical need, promoting domestic drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency, and increasing the accessibility and affordability of drugs and biologics. Voucher recipients receive enhanced communications with review staff throughout the development process, and review decisions are targeted for completion within 1-2 months following submission of an application.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
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