FDA Unveils Second Wave of National Priority Voucher Winners, Featuring Obesity Leaders Lilly and Novo Nordisk

Scientists and staff walk outside the U.S. Food and Drug Administration headquarters, representing the agency’s growing focus on regulatory innovation and public health priorities. (AI-generated for editorial illustration purposes.)

FDA expands National Priority Voucher pilot with six new awardees, bringing total to 15 therapies

The U.S. Food and Drug Administration (FDA) has announced a significant expansion of its Commissioner’s National Priority Voucher (CNPV) pilot program, adding six new recipients to a growing list of therapies chosen for accelerated review under the agency’s new regulatory innovation framework.

The six new awardees Zongertinib for HER2 lung cancer, Bedaquiline for pediatric drug-resistant tuberculosis, Dostarlimab for rectal cancer, Casgevy for sickle cell disease, Orforglipron, and Wegovy for obesity-related conditions bring the total number of voucher holders to 15. The CNPV pilot, launched in June 2025, is designed to fast-track drugs and biologics that address pressing public health challenges, enhance domestic manufacturing capacity, or strengthen national health security.

“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.”

Under the program, companies receiving a National Priority Voucher can see their application review timelines reduced from the standard 10–12 months to as little as one to two months. The accelerated process relies on a “tumor board–style” multidisciplinary review that allows real-time data discussion and cross-specialty decision-making. FDA reviewers reserve the right to extend timelines as needed, but the model aims to achieve near-immediate turnaround for therapies with major potential public benefit.

The initiative draws authority from several key legislative frameworks, including the Federal Food, Drug, and Cosmetic Act, the 21st Century Cures Act, and the Food and Drug Administration Safety and Innovation Act. These statutes enable the FDA to pilot innovative regulatory methods that improve efficiency without compromising the agency’s safety and efficacy standards.

The FDA said that both external applications and internal nominations from review divisions were considered in selecting the latest cohort. The six new entrants reflect the diversity of the agency’s national priorities from chronic disease and cancer prevention to infectious disease and health affordability. Drugs targeting obesity and metabolic health including Novo Nordisk’s Wegovy and Eli Lilly’s Orforglipron represent a growing policy focus as the government moves to expand access to obesity treatments through federal programs such as Medicare and Medicaid.

In parallel, the agency released a detailed CNPV program overview, outlining eligibility, submission procedures, and selection criteria. Companies chosen for the pilot receive tangible regulatory advantages, including rolling reviews, enhanced communication channels, and access to accelerated approval pathways when statutory requirements are met.

“The CNPV pilot program offers an unprecedented opportunity to reduce drug and biological product review times from 10–12 months to just 1–2 months,” the FDA said in its fact sheet. “It reflects our broader commitment to modernizing regulatory frameworks for greater agility to meet emerging public health needs.”

The CNPV initiative also serves broader policy objectives beyond faster approvals. The agency has tied participation to commitments around affordability, domestic production, and public health preparedness positioning the program at the intersection of healthcare innovation and national security. Companies awarded vouchers are expected to support U.S. manufacturing investments and supply chain resilience, part of a government-wide effort to reduce dependence on foreign pharmaceutical production.

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Commissioner Makary described the program as part of a long-term shift toward “collaborative, transparent, and team-based regulatory science.” By integrating the tumor board model a multi-specialty review format commonly used in oncology into the drug evaluation process, the FDA hopes to balance rigor with speed while maintaining its statutory standards of safety and efficacy.

With 15 products now enrolled, the CNPV program is expected to serve as a testbed for future reforms aimed at reducing administrative bottlenecks and encouraging innovation tied to public value. FDA officials said they will continue monitoring outcomes and gathering feedback from stakeholders before determining whether to expand the program in 2026.

Source: U.S. Food and Drug Administration Commissioner’s National Priority Voucher (CNPV) Pilot Program, June & Nov 2025.