India, April 24 -- Regeneron Pharmaceuticals (REGN) announced the FDA has granted accelerated approval for Otarmeni, the first gene therapy and second new molecular entity approved under the FDA Commissioner's National Priority Voucher program. The FDA approval is based on results from the pivotal CHORD trial. Regeneron will provide Otarmeni at no cost to clinically eligible individuals in the U.S.
Otarmeni is an adeno-associated virus vector-based gene therapy 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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