HUTCHMED Announces Sovleplenib Granted US FDA Orphan Drug Designation for Primary Immune Thrombocytopenia

HUTCHMED announced that the US FDA has granted Orphan Drug Designation to sovleplenib for treating primary immune thrombocytopenia (ITP), a rare autoimmune disorder. The designation provides 7 years of US market exclusivity upon approval, along with other development incentives. Sovleplenib is a novel, selective oral spleen tyrosine kinase inhibitor currently under regulatory review in China for ITP and warm antibody autoimmune hemolytic anemia.