FDA Approves Regeneron's Otarmeni as First Gene Therapy for Genetic Hearing Loss
Regeneron Pharmaceuticals has received FDA approval for Otarmeni, a gene therapy designed to treat severe-to-profound sensorineural hearing loss associated with the OTOF gene. This approval is based on the CHORD trial, which demonstrated significant hearing improvements in participants. Otarmeni is the first gene therapy to restore neurosensory function to normal levels and will be provided for free in the U.S. by Regeneron. The therapy uses an adeno-associated virus vector to deliver a working copy of the OTOF gene, aiming to restore natural hearing in affected individuals. 
