Federal Register #FDA-2026-N-4573

FDA Awards Priority Review Voucher for AVLAYAH (tividenofusp alfa-eknm) by Denali Therapeutics

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued a priority review voucher for a rare pediatric disease product: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEM Highlight: - Denali Therapeutics Inc. is the manufacturer (OEM) of the awarded product - Product Awarded: - AVLAYAH (tividenofusp alfa-eknm) Injection - Indicated for treatment of neurologic manifestations of Hunter syndrome (Mucopolysaccharidosis type II, MPS II) in pediatric patients - Award Details: - The award is a priority review voucher, granted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) - The voucher is given to sponsors of approved rare pediatric disease product applications meeting specific criteria - Notable Requirements: - Product must be approved for a rare pediatric disease and meet FDA criteria for the voucher - Place of Performance/Contracting Office: - Food and Drug Administration, Silver Spring, MD

Description

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The voucher is awarded under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that AVLAYAH (tividenofusp alfa-eknm), approved March 24, 2026, and manufactured by Denali Therapeutics Inc., meets the criteria for a priority review voucher. This notice serves to inform the public of the award of the priority review voucher.

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