Otarmeni (lunsotogene parvec-cwha)

BL 125874

Otarmeni (lunsotogene parvec-cwha)

BL 125874

U.S. License Holder:

Regeneron Pharmaceuticals, Inc.

Date of License:

Aprio-23-2026

Last Update:

May-23-2026

approved_indications FDA-Approved Indications

OTARMENI (lunsotogene parvec-cwha) is indicated for the treatment of pediatric and adult patients with severe-to-profound and profound sensorineural hearing loss (any frequency greater than 90 dB HL) associated with molecularly confirmed biallelic variants in the OTOF gene, preserved outer hair cell function, and no prior cochlear implant in the same ear.

Methodology

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