Sanofi SA announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Wayrilz (rilzabrutinib), a novel oral Bruton's tyrosine kinase inhibitor, for the treatment of warm autoimmune hemolytic anemia (wAIHA). Additionally, the Japanese Ministry of Health, Labour and Welfare has provided rilzabrutinib with orphan drug designation for the same condition. These designations are based on clinical data from the ongoing LUMINA 2 phase 2b study and the new LUMINA 3 phase 3 study.

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