← Back to The Docket APR 23 2026
APPROVED · 99 DAYS AGO
— Otarmeni (lunsotogene parvec-cwha)
$REGN
for Genetic hearing loss
BLA
FDA approved Regeneron's Otarmeni (lunsotogene parvec-cwha), the first-ever gene therapy treatment for genetic hearing loss, under the FDA Commissioner's National Priority Voucher (CNPV) pilot program.
About
Otarmeni is a gene therapy designed to deliver a functional copy of a specific gene directly into the inner ear. This approach aims to address the root genetic cause of hearing loss by potentially restoring the function of sensory cells. For individuals with this inherited condition, it could offer a way to improve hearing ability from an early age.
