FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program
WHY IT MATTERS
This is the first gene therapy approved specifically for inherited hearing loss, offering a potential one-time treatment option for patients with certain genetic forms of deafness who previously had no curative options.
The FDA has approved Otarmeni, a new gene therapy treatment for genetic hearing loss. This is the first-of-its-kind treatment that uses a special virus to deliver healthy genes into the ear to help restore hearing. The approval was fast-tracked through a special FDA program that prioritizes treatments for serious diseases.
The U.S. Food and Drug Administration today approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy.
ASK YOUR DOCTOR
If you or a family member has genetic hearing loss, ask your audiologist or ear specialist whether you might be eligible for Otarmeni and what genetic testing would be needed to determine candidacy.