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FDA greenlights Otarmeni: first gene therapy to restore hearing in OTOF-related deafness, Regeneron to provide it free in the U.S.

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Source: Regeneron
FDA greenlights Otarmeni: first gene therapy to restore hearing in OTOF-related deafness, Regeneron to provide it free in the U.S.
Photo: Regeneron
TL;DR Summary

The FDA granted accelerated approval for Otarmeni (lunsotogene parvec-cwha), a one-time gene therapy for severe-to-profound OTOF-related hearing loss, based on CHORD trial results showing 80% of participants reached a key hearing threshold at 24 weeks and 42% achieved normal hearing by 48 weeks; Regeneron will provide Otarmeni free to eligible U.S. patients as part of access programs, with continued confirmatory trials and safety monitoring ongoing.

Topics:business#fda-accelerated-approval#gene-therapy#healthcare#hearing-loss#otarmeni#otof
Share this article
  1. 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.  Regeneron
  2. New Gene Therapy Enables Children With a Rare Form of Deafness to Hear  The New York Times
  3. FDA Approves First-Ever Gene Therapy to Restore Hearing  WSJ
  4. FDA approves first gene therapy for genetic hearing loss  NBC News
  5. Regeneron ushers in new era with inaugural gene therapy approval  Fierce Pharma

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