Benzinga | Nov 10, 2021 08:13AM EST

MEI Pharma And Kyowa Kirin Receive Orphan Drug Designation For Zandelisib For The Treatment Of Follicular Lymphoma

MEI Pharma, Inc. (NASDAQ:MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, and Kyowa Kirin, Inc., an affiliate of Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151), a global specialty pharmaceutical company that utilizes the latest biotechnology to discover and deliver novel medicines, today announced that the U.S. Food and Drug Administration (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 200,000 individuals in the U.S. ODD granted therapies entitle companies to development incentives including tax credits for qualified clinical trials, exemptions from certain FDA application fees, and the potential of seven years of marketing exclusivity in the event of regulatory approval. ODD does not shorten the duration of the regulatory review or approval process. For more information on ODD, please visit the FDA website at https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products.