Shots:
- Otarmeni was approved under CNPV for pediatric & adult pts with sev. to profound and profound sensorineural hearing loss due to biallelic OTOF gene variants, with preserved outer hair cell function & no prior cochlear implant. It will be provided free of charge in the US by Regeneron
- Approval was based on the P-I/II (CHORD) trial assessing Otarmeni in 20 pts (10mos.-16yrs.), where 10 pts received it in 1 ear, while 10 received it in both; pts enrollment (<18yrs.) ongoing in the US, UK, Spain, Germany & Japan
- Trial showed 80% (16/20) achieved ≤70 dB HL at 24wks. (1 subject achieved it by 48wks.), meeting the 1EP, & 70% reached ABR at ≤90 dB at 24wks. (2EP), with all responders maintaining benefit to 48wks. & 42% (5/12) achieving normal hearing (≤25 dB HL)
Ref: Regeneron | Image: Regeneron | Press Release
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