A U.S. federal court asked the Food and Drug Administration to grant orphan drug exclusivity to Eagle Pharmaceuticals Inc.'s blood cancer medicine, Bendeka.
The seven-year exclusivity would prevent generic versions of the drug, a formulation of bendamustine hydrochloride, from entering the market until December 2022 rather than November 2019.
Bendeka, which is also sold as Treanda, is used to treat patients with chronic lymphocytic leukemia and those with indolent B cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with Biogen and Genentech's rituximab.
The decision from the U.S. District Court for the District of Columbia comes two years after the FDA denied Eagle's request to grant the medicine orphan drug exclusivity. At the time, Eagle had said it would consider options to challenge the regulator's decision.
Orphan drug exclusivity is granted to drugs or biologics that treat rare diseases or conditions affecting fewer than 200,000 patients in the U.S.
The designation typically provides the drug developer with a seven-year period of U.S. marketing exclusivity upon approval; bars the FDA from approving any other application for the same drug for the same orphan disease; and offers certain financial incentives that can help support its development.
Teva Pharmaceutical Industries Ltd. is responsible for all commercial activities for Bendeka in the U.S., including promotion and distribution. Eagle is responsible for obtaining all regulatory approvals, conducting post-approval clinical studies, and supplying the drug product to Teva.
