Federal regulators on April 23 approved the first gene therapy to restore hearing, just two months after the therapy’s maker formally requested a license.
The Food and Drug Administration approved the Regeneron therapy, Otarmeni, for children and adults with severe or profound hearing loss associated with OTOF gene variants.
The approval came 61 days after Regeneron filed for a biologics license, under a new effort known as the Commissioner’s National Priority Voucher Program that emphasizes quickly reviewing applications for products that address unmet needs.
“Today’s approval is a significant milestone in the treatment of genetic hearing loss,” Dr. Marty Makary, the FDA’s commissioner, said in a statement….