Top-line results from FORWARD phase III clinical trial of fostamatinib in patients with warm autoimmune hemolytic anemia.
Rigel Pharmaceuticals, Inc. announced top-line efficacy and safety data from the FORWARD Phase III clinical trial , a global, multi-center, randomized, double-blind, placebo-controlled trial of fostamatinib in patients with warm autoimmune hemolytic anemia (wAIHA).
The trial did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population. In a post-hoc regional analysis of U.S., Canadian, Australian, and Western European trial sites, patients treated with fostamatinib had a favorable durable hemoglobin response compared to placebo, whereas in the Eastern European trial sites patients did not. Rigel plans to continue analyzing the data to understand the geographical differences in patient disease characteristics and outcomes and discuss these findings with the FDA. The safety and tolerability profile in the FORWARD trial was consistent with the existing fostamatinib safety database.
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