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Ovid Therapeutics secures US FDA orphan drug designation for epilepsy therapy

Ovid Therapeutics Inc. secured the U.S. Food and Drug Administration's orphan drug designation for TAK-935/OV935 to treat a severe and rare form of childhood epilepsy.

The Dravet syndrome treatment has completed four phase 1 clinical trials. Takeda Pharmaceutical Co. Ltd. and Ovid formed a global collaboration to develop and commercialize TAK-935/OV935 for the treatment of developmental and epileptic encephalopathies in January.

The FDA's orphan drug designation is granted to drugs and biologics intended to treat rare diseases or conditions with a prevalence of fewer than 200,000 people in the U.S.

This designation includes eligibility for tax credits, study-design assistance and several years of market exclusivity for TAK-935/OV935 upon regulatory approval.