Issuance of Priority Review Voucher; Rare Pediatric Disease Product; OTARMENI (lunsotogene parvec-cwha)

摘要

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 Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that OTARMENI (lunsotogene parvec-cwha), approved April 23, 2026, manufactured by Regeneron Pharmaceuticals, Inc., meets the criteria for a priority review voucher.