If approved, Regeneron’s Otarmeni will be the first gene therapy for OTOF-related hearing loss in the European Union. Regeneron Pharmaceuticals announced the European Medicines Agency (EMA) has accepted for review its marketing authorization application (MAA) for Otarmeni (lunsotogene parvec)....
No actionable change yet — EMA acceptance is a regulatory milestone, not an approval; audiologists treating OTOF-related hearing loss patients should monitor the review outcome before adjusting referral or counseling pathways.
EMA acceptance of the first gene therapy marketing application for hereditary hearing loss marks a pivotal regulatory moment that could fundamentally expand treatment options beyond conventional amplification and cochlear implants for a defined genetic subpopulation.
- 01EMA has accepted Regeneron's marketing authorization application for Otarmeni (lunsarnab) for formal review.
- 02Otarmeni targets OTOF-related hearing loss, a rare autosomal recessive form of congenital deafness.
- 03If authorized, it would be the first gene therapy approved for hearing loss in the European Union.
- 04Acceptance for review does not equal approval; a full EMA assessment process must be completed.
- 05Regeneron's therapy (also known as lunsarnab) has also been under regulatory scrutiny in the US (FDA).
Otarmeni (lunsarnab) would be the first gene therapy approved for hearing loss in the EU if authorized.
press releasesupportedThe EMA has accepted Regeneron's marketing authorization application for lunsarnab for review.
press releasesupported
