Regeneron secures first FDA approval for gene therapy treating rare inherited hearing loss

Regeneron announced that the U.S. Food and Drug Administration has approved its gene-based treatment Otarmeni, marking the first approval of a therapy for inherited hearing loss.

The therapy is designed for a rare genetic form of hearing impairment, and the FDA decision represents a milestone for gene-therapy approaches in otology.

Regeneron said it will make the treatment available at no charge to patients in the United States.