FDA ApprovedUnited States
First FDA-Approved Gene Therapy for Genetic Hearing Loss
OTARMENI (lunsotogene parvec-cwha) — gene therapy for severe genetic hearing loss from biallelic OTOF variants
FDA accelerated approval on 23 April 2026 for OTARMENI (lunsotogene parvec-cwha) suspension — a one-time intracochlear gene therapy — for pediatric and adult…
This is for children and adults with severe genetic hearing loss from confirmed OTOF gene changes who may be candidates for labelled US OTARMENI gene therapy…