HUTCHMED Announces Sovleplenib Granted US FDA Orphan Drug Designation for Autoimmune Hemolytic Anemia

HUTCHMED announced that the US FDA has granted Orphan Drug Designation to sovleplenib for treating autoimmune hemolytic anemia (AIHA), marking the second orphan designation for the drug following its recent designation for primary immune thrombocytopenia (ITP). The designation provides 7 years of US market exclusivity upon approval, along with other development incentives. NDAs for sovleplenib are currently under regulatory review in China for primary ITP and warm AIHA.