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Press Release: Sanofi’s rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia
Sanofi’s rilzabrutinib, branded as Wayrilz, has received Breakthrough Therapy designation from the FDA in the US and Orphan Drug designation in Japan for the treatment of warm autoimmune hemolytic anemia (wAIHA). These designations highlight the urgent unmet need for therapies in wAIHA, a rare autoimmune disorder, and are supported by clinical data from the ongoing LUMINA 2 phase 2b study. Rilzabrutinib, an oral BTK inhibitor, is already approved for immune thrombocytopenia (ITP) in several regions and is being investigated for other rare immune-mediated diseases.