HUTCHMED (00013) has 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 leads to an increased risk of bleeding. Sovleplenib is a novel, highly selective oral spleen tyrosine kinase (Syk) inhibitor.
The FDA's Orphan Drug Designation program is designed to provide orphan drug status to drugs and biologics intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or conditions affecting 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, as well as tax credits for qualified clinical trials, exemption from user fees under the Prescription Drug User Fee Act (PDUFA), and access to specialized 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. These two applications are based on positive data from the pivotal ESLIM-01 and ESLIM-02 studies.
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