United States, April 24 -- The U.S. Food and Drug Administration approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy. Otarmeni is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency >90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene.Following the publication of powerful results of hearing restoration in the New England Journal of Medicine, the FDA acted swiftly to grant a national priority voucher for an accelerated review. Today's approval was issued 61 days after BLA filing, marking the sixth approval under the Commissioner's National Priority Voucher (...