WASHINGTON (dpa-AFX) - Friday, Regeneron Pharmaceuticals, Inc. (REGN) announced that Otarmeni has been accepted by European Medicines Agency for review under Accelerated Assessment the Marketing Authorization Application for the treatment of biallelic OTOF variant-associated hearing loss.
The application is backed by data from the pivotal CHORD clinical trial, evaluating the safety, tolerability and efficacy of Otarmeni in infants, children and adolescents with OTOF-related hearing loss.
If approved, Otarmeni will be the first gene therapy for OTOF-related hearing loss in the European Union.
Earlier, Otarmeni received Orphan Designation from the European Medicines Agency.
In the pre-market hours, REGN is trading at $645.00, up 0.38 percent on the Nasdaq.
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