June 17, 2025

The U.S. FDA today announced a Commissioner’s National Priority Voucher (CNPV) program. The ultimate goal of the program is ‘to bring more cures and meaningful treatments to the American public.’

The new CNPV program will:

shorten review timeline from 10-12 months to 1-2 months (from final submission date)

have applications reviewed by a multi-disciplinary team rather than the standard review approach

allow Sponsors to submit the majority of the application before the clinical trial is complete

include enhanced communication between the FDA and the sponsor.

There will be a limited number of vouchers issued in the first year to companies that are aligned with the national health priorities of:

Addressing a health crisis in the U.S.

Delivering more innovative cures for the American people.

Addressing unmet public health needs.

Increasing domestic drug manufacturing as a national security issue.

Vouchers can be directed by the FDA towards a specific investigational new drug of a company or be granted to a company as an undesignated voucher, allowing a company to use the voucher for a new drug at the company’s discretion and consistent with the program’s objectives.

the vouchers are not transferable but are retained if the company is acquired by another company

vouchers must be redeemed within 2 years

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May 2, 2025

Novo Nordisk ($NVO) announced that the FDA has accepted its application for an oral version of Wegovy (semaglutide). While not specifically stated, the Q4 2025 PDUFA date implies a Priority Review Voucher was used for this submission.

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April 29, 2025

Abeona Therapeutics Inc ($ABEO) received FDA approval today for Zevaskyn (prademagene zamikeracel) for wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa. With this approval they received a Rare Pediatric Disease Priority Review Voucher.

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April 17, 2025

Regeneron Pharmaceuticals Inc $REGN redeems a priority review voucher for a supplemental Biologics License Application for EYLEA HD (aflibercept). The sBLA seeks approval for EYLEA HD for both the treatment of macular edema following retinal vein occlusion (RVO), and for broadening the dosing schedule to include every 4-week (monthly) dosing across approved indications.

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February 27, 2025

Zevra Therapeutics, Inc. $ZVRA announced today that they have entered into an agreement with an undisclosed buyer to sell their priority review voucher for $150 million. The PRV was awarded to Zevra in September 2024 in conjunction with the approval of Miplyffa.

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February 14, 2025

Bavarian Nordic A/S $BAVA.CO was issued a Tropical Disease PRV following FDA approval of Vimkunya (chikungunya vaccine, recombinant) for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older.

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February 12, 2025

U.S Congressman Michael McCaul (representing the 10th District of Texas) reintroduces the Give Kids a Chance Act that seeks to extend the FDA Rare Pediatric Disease Priority Review Voucher program to September 2029.

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Press Release

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Full Bill

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February 11, 2025

SpringWorks Therapeutics, Inc. $SWTX was issued a Rare Pediatric Disease PRV following FDA approval of Gomekli (mirdametinib) for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.

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January 31, 2025

Novartis $NVS stated at their Q4 earnings that they intend to use a PRV with their filing for remibrutinib in chronic spontaneous urticaria (CSU).

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