Posted by Michael Wonder on 23 Apr 2026
Otarmeni (lunsotogene parvec-cwha) approved by FDA as first and only gene therapy for genetic hearing loss; Regeneron to provide Otarmeni for free in the US
23 April 2026 - Regeneron Pharmaceuticals today announced the US FDA has granted accelerated approval for Otarmeni (lunsotogene parvec-cwha), the first gene therapy and second new molecular entity approved under the FDA Commissioner’s National Priority Voucher program.
Otarmeni is an adeno-associated virus vector-based gene therapy indicated for the treatment of paediatric and adult patients with severe toprofound and profound sensorineural hearing loss (any frequency >90 decibel hearing level [dB HL]) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear.
Otarmeni, formerly known as DB-OTO, is the first and only in vivo gene therapy for OTOF-related hearing loss and will be made available by Regeneron for free in the US.
