MEIP - MEI Pharma and Kyowa Kirin get FDA orphan drug designation for zandelisib

MEI Pharma (NASDAQ:MEIP) and Kyowa Kirin announce that the U.S. FDA granted orphan-drug designation (ODD) to zandelisib for the treatment of follicular lymphoma. Orphan-drug designation is granted by the FDA to a drug or biologic intended to treat a rare disease or condition, which generally includes a disease or condition that affects fewer than 200K individuals in the U.S. ODD granted therapies entitle companies to development incentives including tax credits for qualified trials, exemptions from certain FDA application fees, and the potential of seven years of marketing exclusivity in the event of regulatory approval. The companies had dosed the first patient in a Phase 3 study of zandelisib known as COASTAL, in August.

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MEI Pharma and Kyowa Kirin get FDA orphan drug designation for zandelisib