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.
