Regeneron Pharmaceuticals (REGN) said Friday the European Medicines Agency has accepted for accelerated assessment its marketing authorization application for Otarmeni to treat OTOF-related hearing loss.
The gene therapy, previously known as DB-OTO, targets biallelic OTOF variant-associated hearing loss, the company said.
The therapy received accelerated approval in the US in April, Regeneron said, adding it plans regulatory submissions in other markets, including Japan.
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