FDA Approves First Gene Therapy to Treat Deafness

‘Today’s approval is a significant milestone in the treatment of genetic hearing loss,’ the agency’s commissioner said.

Dr. Marty Makary, the Food and Drug Administration's commissioner, in an undated file photograph. Madalina Vasiliu/The Epoch Times

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.