Federal Register #FDA-2026-N-3004

FDA Awards Priority Review Voucher for YUVIWEL (navepegritide)

This announcement details the FDA's award of a priority review voucher for YUVIWEL (navepegritide), a rare pediatric disease product: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEM Highlight: - Ascendis Pharma Growth Disorders (A/S) is the manufacturer of YUVIWEL (navepegritide) - Product Details: - YUVIWEL (navepegritide) is indicated to increase linear growth in pediatric patients aged 2 years and older with achondroplasia with open epiphyses - Award Information: - The FDA issued a priority review voucher under the Federal Food, Drug, and Cosmetic Act - The voucher is granted to sponsors of approved rare pediatric disease product applications meeting specific criteria - Notable Requirements: - No procurement of products or services is requested in this notice; this is an award announcement only - The notice confirms YUVIWEL (navepegritide) meets the criteria for the voucher - Place of Performance/Contracting Office: - Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Room 5324, Silver Spring, MD 20993-0002

Description

The Food and Drug Administration (FDA) announces the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The voucher is awarded under the Federal Food, Drug, and Cosmetic Act to sponsors of approved rare pediatric disease product applications that meet specific criteria. YUVIWEL (navepegritide), approved on February 27, 2026, and manufactured by Ascendis Pharma Growth Disorders (A/S), has been determined to meet these criteria. The product is indicated to increase linear growth in pediatric patients aged 2 years and older with achondroplasia with open epiphyses.

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