CNPV Dashboard
Latest information on the Commissioner's National Priority Voucher pilot program
Background
Commissioner’s National Priority Voucher (CNPV)
A pilot program announced on June 17, 2025, by the U.S. Food and Drug Administration (FDA). The program offers a limited number of non-transferable vouchers to sponsors whose clinical assets align with key U.S. national health priorities. The CNPV pilot operates in addition to the existing Priority Review Voucher (PRV) program.
The pilot is intended to explore pathways to dramatically reduce review times for drug and biological product applications and manufacturing or efficacy supplements. These vouchers provide an expedited review (targeting 1–2 months following application acceptance) of the designated application instead of the typical 10–12 months or priority-review 6 months timeline, with enhanced interaction with FDA reviewers and a multi-disciplinary team-based review process.
CNPV selection criteria
Potential candidates for a voucher may be submitted via one of two pathways:
- Companies may apply directly to the CNPV program.
- Internal FDA stakeholders (e.g., reviewers, review divisions, Center leadership) may nominate potential product candidates.
Products are selected that align with U.S. national health priorities, which are as follows:
- Public health crisis response: Products addressing urgent/emerging threats or significant population impact.
- Innovative breakthrough therapies: Transformative treatments with novel mechanisms that fundamentally change disease management.
- Large unmet medical needs: Therapies for conditions where existing treatments inadequately address patient outcomes.
- Onshoring and supply chain resilience: Onshoring drug development/manufacturing to strengthen U.S. domestic capacity, reduce foreign dependencies, and improve national security.
- Affordability: Approaches that improve overall value through reduced costs to the healthcare system or that enhance access to important products.
Vouchers may be granted by the FDA for review of a company's specific drug/biological product application. When the pilot program was first announced, it was stated that vouchers may be issued for a specific drug/biologic product or as an undesignated voucher for the awarded company to select which product/indication to redeem it on. However, no undesignated vouchers have been issued, and revised CNPV documentation no longer references them, suggesting they are no longer part of the pilot program.
CNPV compared to PRVs
Key differences between the CNPV pilot program compared to the existing PRV programs include:
- an ultra-fast review timeline of 1-2 months target vs. 6-10 months
- the inability to sell or transfer vouchers to another party/company
- an expiry of two years from voucher issuance
Please refer to the accompanying infographic for a detailed overview and feature comparison of the different priority voucher programs.
CNPVs awarded
October 16, 2025
November 06, 2025
December 15, 2025
December 19, 2025
April 24, 2026
May 5, 2026
Initially, five vouchers were expected to be issued under the pilot program. However, a total of 21 vouchers have been issued to date for specific products and indications. The tables below indicate the companies, products and product indications to which these vouchers have been awarded.
CNPV review process
All CNPV applications are reviewed by the appropriate review teams in the relevant FDA center. The FDA is exploring the use of internally developed agentic AI-based tools to streamline specific components of the review process (e.g., filing checklist assessments) to expedite portions of the application process.
Review teams conduct independent scientific analyses and share their recommendations with a multidisciplinary “tumor board–style” panel known as the CNPV Review Council for collaborative discussion.
CNPV review timeline
What happens during a CNPV review council meeting?
- The primary review team present to the Council and provide their preliminary scientific recommendation and supporting rationale on relevant portions of the application
- The Council provide a non-binding scientific recommendation determined by vote using pre-specified voting questions
- The Center Director consider the preliminary recommendation of the primary review team and the Council and convey a non-binding scientific recommendation to the review team
Decisions regarding drug approval remain within the FDA Centers.
For further information on the CNPV Review Council please refer to the FDA Staff Manual Guide:
FDA Staff Manual Guides (SMG), Volume III – General Administration. FDA Councils and Committees: Commissioner’s National Priority Voucher Review Council (Effective Date: January 15, 2026)
CNPV FDA town hall slides
The FDA held an internal town hall on February 3, 2025 on the CNPV program. The slides can be viewed in the embed below.
CNPV tracker
CNPV approvals
Augmentin XR (amoxicillin-clavulanate potassium)
December 9, 2025: Augmentin XR had been previously approved but was no longer marketed and the product was discontinued. This approval reinstated the availability of supply for Augmentin XR.
Hernexeos (zongertinib)
February 26, 2026: Hernexeos was approved for adults with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations as detected by an FDA-authorized test. The application was filed on January 13, 2026 and was approved 44 days later.
Tecvayli (teclistamab) + Darzalex (daratumumab hyaluronidase-fihj)
March 5, 2026: The FDA approved today the teclistamab and daratumumab in combination was approved for relapsed or refractory multiple myeloma who have received at least one prior line of therapy. Approved 55 days from the filing (this application was also under real-time review so it is likely 55 days from the application being complete not when the submission was started).
Wegovy HD (semaglutide)
March 20, 2026: Wegovy HD was approved for for weight loss and long-term maintenance of weight loss for certain adult patients. The decision was granted 54 days after filing.
Foundayo (orforglipron)
April 1, 2026: Foundayo was approved for use in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition. This approval is the first novel drug approved under the CNPV program.
Otarmeni (lunsotogene parvec-cwha)
April 23, 2026: Otarmeni received accelerated approval for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 decibel hearing level [dB HL]) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear. The treatment will be made available by Regeneron for free in the U.S.
Bizengri (zenocutuzumab-zbco)
May 8, 2026: Bizengri was approved for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy.
Citations
- U.S. Food and Drug Administration. Commissioner’s National Priority Voucher (CNPV) pilot program. https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program
- U.S. Food and Drug Administration. FDA to issue new Commissioner’s National Priority Vouchers to companies supporting U.S. national interests. https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests
- U.S. Food and Drug Administration. FDA awards first-ever national priority vouchers to nine sponsors. https://www.fda.gov/news-events/press-announcements/fda-awards-first-ever-national-priority-vouchers-nine-sponsors
- U.S. Food and Drug Administration. FDA awards second batch of national priority vouchers. https://www.fda.gov/news-events/press-announcements/fda-awards-second-batch-national-priority-vouchers
- U.S. Food and Drug Administration. FDA proactively awards national priority voucher based on strong Phase 3 study results. https://www.fda.gov/news-events/press-announcements/fda-proactively-awards-national-priority-voucher-based-strong-phase-3-study-results
- U.S. Food and Drug Administration. FDA grants two national priority vouchers. https://www.fda.gov/news-events/press-announcements/fda-grants-two-national-priority-vouchers
- U.S. Food and Drug Administration. FAQs: Commissioner’s National Priority Voucher pilot program. https://www.fda.gov/news-events/press-announcements/faqs-commissioners-national-priority-voucher-pilot-program
- U.S. Food and Drug Administration. CDER, CBER, OCE Town Hall Pilot Program Overview. https://www.fda.gov/media/190927/download?attachment
- U.S. Food and Drug Administration. First approval under Commissioner’s National Priority Voucher pilot program strengthens domestic antibiotic development. https://www.fda.gov/news-events/press-announcements/first-approval-commissioners-national-priority-voucher-pilot-program-strengthens-domestic-antibiotic
- U.S. Food and Drug Administration. FDA grants second approval under National Priority Voucher pilot program. https://www.fda.gov/news-events/press-announcements/fda-grants-second-approval-under-national-priority-voucher-pilot-program