HUTCHMED's sovleplenib gets FDA orphan drug designation for autoimmune hemolytic anemia
HCM•HUTCHMED received FDA orphan drug designation for sovleplenib to treat autoimmune hemolytic anemia, making it eligible for seven years of US market exclusivity if approved, as well as development incentives.
1. FDA designation
HUTCHMED said the FDA granted orphan drug designation to sovleplenib for autoimmune hemolytic anemia. The designation is sovleplenib’s second from the FDA, following one for primary immune thrombocytopenia in October 2026.
2. Applications in China
Applications in China for primary immune thrombocytopenia and warm autoimmune hemolytic anemia remain under review by the National Medical Products Administration. HUTCHMED said the pivotal ESLIM-01 and ESLIM-02 trials in China produced positive results supporting those applications.
