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The US Food and Drug Administration approves the first gene therapy for inherited hearing loss.
FDA approved Regeneron's Otarmeni, the first gene therapy for inherited hearing loss.
KEY POINTS
- Regeneron will provide Otarmeni free to US patients despite typical million-dollar gene therapy prices.
- In a trial, 16 of 20 children had improved hearing within five months after Otarmeni treatment.
- Otarmeni is administered with a procedure similar to cochlear implant surgery and showed no major safety issues.
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