Regeneron receives approval under the Commissioner's National Priority Voucher for Otarmeni (DB-OTO)

Regeneron Pharmaceuticals has received accelerated approval under the FDA’s Commissioner’s National Priority Voucher (CNPV) programme for Otarmeni (DB-OTO), a gene therapy for OTOF-related hearing loss.

The company also announced the treatment will be provided free of charge in the U.S.

While not yet officially disclosed, Otarmeni would also likely qualify for a Rare Paediatric Disease Priority Review Voucher (PRV). The therapy targets a rare inherited form of childhood hearing loss and meets the eligibility requirements for the Rare Paediatric Disease PRV programme.

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Source: Press Release