HUTCHMED's Sovleplenib gains US FDA orphan drug designation for autoimmune hemolytic anemia
HCM•HUTCHMED said the FDA granted orphan drug designation to sovleplenib for autoimmune hemolytic anemia, making it the drug’s second FDA orphan designation.
1. FDA designation
The designation offers development incentives, including seven years of US market exclusivity upon regulatory approval. Chinese regulators are reviewing sovleplenib applications for primary immune thrombocytopenia and warm autoimmune hemolytic anemia, supported by positive results from the pivotal ESLIM-01 and ESLIM-02 trials, respectively.
