The U.S. Food and Drug Administration is taking steps to lower healthcare costs, awarding priority review vouchers to two investigational drugs on December 19, 2025, that show promise in increasing affordability for American patients. This move signals a new focus on accessibility alongside medical innovation.

New Pathway for Affordable Medicines

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The FDA’s Commissioner’s National Priority Voucher (CNPV) pilot program is designed to speed up the review of drugs that address critical national needs, including affordability.

  • The FDA awarded vouchers to Enlicitide decanoate, an oral PCSK9 inhibitor for lowering LDL cholesterol, and Sacituzumab Tirumotecan, a drug targeting trophoblast cell-surface antigen 2 (TROP2) for cancer treatment.
  • This is the first time the agency has awarded vouchers specifically for potential affordability benefits.
  • The CNPV program aims to cut review times for promising drugs to as little as 1-2 months after application submission.
  • Eighteen products have now received a voucher under the CNPV pilot program since its launch in June 2025.

“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.”

Accelerated Review for Cholesterol Control

Enlicitide decanoate, an oral PCSK9 inhibitor, offers a potential new approach to lowering LDL cholesterol, often called “bad” cholesterol. High cholesterol is a major risk factor for heart disease, and current treatments can be expensive or require injections. The voucher aims to expedite the review of this potentially more accessible oral medication.

Targeted Cancer Therapy Gets a Boost

Sacituzumab Tirumotecan is a trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate. This means it’s designed to deliver medication directly to cancer cells expressing the TROP2 protein, potentially minimizing side effects and improving treatment efficacy. The voucher will help accelerate its path to potential approval.

On December 9, the agency announced its first review decision under the program, achieving significant time savings compared to a typical review timeline.

About the CNPV Pilot Program

The CNPV pilot program was established to prioritize the review of products addressing key national priorities. These include responding to U.S. public health crises, delivering innovative cures, addressing unmet medical needs, bolstering domestic drug development and manufacturing, and—crucially—increasing the accessibility and affordability of drugs and biologics. Voucher recipients benefit from enhanced communication with FDA review staff and a significantly faster review process.

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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.