HUTCHMED (00013): Sovleplenib granted FDA orphan drug designation for the treatment of primary immune thrombocytopenia

HUTCHMED (00013) announced that sovleplenib has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of primary immune thrombocytopenia. Immune thrombocytopenia is an autoimmune disease that increases the risk of bleeding. Sovleplenib is a novel, highly selective oral spleen tyrosine kinase (Syk) inhibitor. The FDA's Orphan Drug Designation program is intended to provide orphan drug designation for drugs and biologics used for the safe and effective treatment, diagnosis or prevention of rare diseases or conditions that affect fewer than 200,000 people in the United States. If approved by the FDA for the designated indication, a drug granted orphan drug designation is eligible for seven years of U.S. market exclusivity from the date of approval, and may receive tax credits for qualifying clinical trials, exemption from user fees under the Prescription Drug User Fee Act (PDUFA), and professional regulatory guidance from the FDA during clinical development. In China, two new drug applications for sovleplenib for the treatment of primary immune thrombocytopenia and warm antibody autoimmune hemolytic anemia are currently under review by the National Medical Products Administration of China. These two applications are based on positive data from the pivotal ESLIM-01 and ESLIM-02 studies, respectively.