FDA approves first gene therapy for genetic hearing loss

The Food and Drug Administration on Thursday approved Regeneron’s Otarmeni, the first gene therapy for genetic hearing loss

The Food and Drug Administration on Thursday approved Regeneron’s Otarmeni, the first gene therapy for genetic hearing loss.

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The drugmaker said it will offer the drug for free to U.S. patients.

Otarmeni is approved to treat a very rare form of hearing loss that affects about 50 babies born in the U.S. each year and is caused by a mutation in a gene called OTOF. The approval was granted under the Commissioner’s National Priority Voucher, an FDA pilot program intended to fast-track drug reviews.