FDA Grants Accelerated Approval to Gene Therapy for OTOF-Related Hearing Loss

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Regeneron Pharmaceuticals

The U.S. Food and Drug Administration has granted accelerated approval to an adeno-associated virus–based gene therapy for patients with severe-to-profound hearing loss caused by OTOF gene variants. Clinical data showed improvements in hearing thresholds in a majority of participants, with some achieving levels consistent with functional or near-normal hearing, while continued approval remains contingent on confirmatory trial outcomes.

👉 Read the full article: Otarmeni™ (lunsotogene parvec-cwha) Approved by FDA as First and Only Gene Therapy for Genetic Hearing Loss; Regeneron to Provide Otarmeni for Free in the U.S.

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