Federal Register #2026-08913

FDA Awards Priority Review Voucher for Regeneron's OTARMENI (lunsotogene parvec-cwha)

This notice announces the FDA's award of a priority review voucher for OTARMENI (lunsotogene parvec-cwha), a rare pediatric disease product: - Government Buyer: - Food and Drug Administration (FDA), under the Health and Human Services Department - OEM Highlight: - Regeneron Pharmaceuticals, Inc. is the manufacturer of OTARMENI - Product Details: - OTARMENI (lunsotogene parvec-cwha) is indicated for pediatric and adult patients with severe-to-profound sensorineural hearing loss due to biallelic OTOF gene variants, with preserved outer hair cell function and no prior cochlear implant in the same ear - Award Details: - FDA issued a priority review voucher under the Federal Food, Drug, and Cosmetic Act for meeting rare pediatric disease criteria - Notable Requirements: - No procurement of products or services is requested; this is solely an award announcement for the voucher - Locations: - FDA and Health and Human Services Department offices are the relevant federal entities

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 Federal Food, Drug, and Cosmetic Act to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that OTARMENI (lunsotogene parvec-cwha), approved April 23, 2026, and manufactured by Regeneron Pharmaceuticals, Inc., meets the criteria for a priority review voucher. OTARMENI is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear.

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