FDA Issues Priority Review Voucher for YUVIWEL (navepegritide) – Rare Pediatric Disease Product
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The U.S. Food and Drug Administration (FDA) has announced the issuance of a Priority Review Voucher (PRV) to Ascendis Pharma Growth Disorders (A/S), the sponsor of YUVIWEL (navepegritide), a drug approved on February 27, 2026, for a rare pediatric disease. The FDA is authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to award such vouchers to sponsors of qualifying rare pediatric disease product applications. A Priority Review Voucher is a transferable, redeemable incentive that entitles the holder to a faster FDA review (typically 6 months instead of the standard 10–12 months) for any future drug application of their choosing. These vouchers are also freely tradeable on the open market and have historically sold for hundreds of millions of dollars. This notice fulfills FDA's statutory obligation to publicly announce the award of a Priority Review Voucher. The issuance confirms that YUVIWEL (navepegritide) met all eligibility criteria under the rare pediatric disease product program, which is designed to incentivize pharmaceutical development for conditions affecting small patient populations, particularly children.
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Key Changes
- FDA officially issues a Priority Review Voucher (PRV) to Ascendis Pharma Growth Disorders (A/S) as of April 1, 2026.
- YUVIWEL (navepegritide) was approved by FDA on February 27, 2026, qualifying it under the rare pediatric disease product program.
- The PRV grants the holder the right to request a 6-month priority review (vs. standard 10–12 months) for any future FDA drug application.
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Obligations
What this law requires
FDA must publicly announce the issuance of a Priority Review Voucher awarded to sponsors of rare pediatric disease product applications
Ascendis Pharma Growth Disorders (A/S) must maintain eligibility criteria compliance for the rare pediatric disease product program to retain the Priority Review Voucher
FDA must determine whether submitted rare pediatric disease product applications meet all eligibility criteria under the rare pediatric disease product program before awarding Priority Review Vouchers
The Priority Review Voucher holder may redeem the voucher to obtain expedited FDA review (6 months instead of 10-12 months) for any future drug application of their choosing