HUTCHMED's sovleplenib receives US FDA orphan drug designation for primary immune thrombocytopenia
HCM•HUTCHMED said the FDA granted orphan drug designation to sovleplenib for primary immune thrombocytopenia, potentially providing seven years of US market exclusivity upon approval. The designation also qualifies the drug for clinical trial tax credits, fee waivers and specialized FDA guidance.
1. FDA designation
HUTCHMED's once-daily oral Syk inhibitor sovleplenib received US FDA orphan drug designation for primary immune thrombocytopenia. The designation may provide seven years of US market exclusivity if the drug is approved, and qualifies it for clinical trial tax credits, fee waivers and specialized FDA guidance.
2. Applications under review
Chinese applications for primary immune thrombocytopenia and warm antibody autoimmune hemolytic anemia remain under review, supported by positive pivotal trial results. ESLIM-01 supported the thrombocytopenia application, while ESLIM-02 supported the anemia application.
