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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 designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia Rilzabrutinib is the first and only investigational BTKi for warm autoimmune hemolytic anemia to be designated Breakthrough Therapy by the FDA Rilzabrutinib helps address complex immune-system dysregulation through multi-immune modulationRilzabrutinib holds global regulatory designations across multiple rare diseases, underscoring its broad therapeutic p
About this update from Sanofi Sa
[{"type":"image","alt":"Sanofi Winthrop Industrie","displaySize":"","headline":null,"caption":"Sanofi Winthrop Industrie","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":84,"url":"https://media.zenfs.com/en/globenewswire.com/c45c40f5ed741dd9c0f5c2f75b8fc137"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/njIuMc8eT.GfUOY8hGPCUA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTExODtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/c45c40f5ed741dd9c0f5c2f75b8fc137","width":300,"height":84}},"lazy":false},{"type":"text","content":"Sanofi’s rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune hemolytic anemia","length":143,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Rilzabrutinib is the first and only investigational BTKi for warm autoimmune hemolytic anemia to be designated Breakthrough Therapy by the FDA","length":142,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":142,"olType":false},{"type":"list","items":[{"val":[{"type":"text","content":"Rilzabrutinib helps address complex immune-system dysregulation through multi-immune modulation","length":95,"tagName":"p"}]},{"val":[{"type":"text","content":"Rilzabrutinib holds global regulatory designations across multiple rare diseases, underscoring its broad therapeutic potential","length":126,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":221,"olType":false},{"type":"text","content":"Paris, February 9, 2026. The US Food and Drug Administration (FDA) has granted a designation as breakthrough therapy to Wayrilz (rilzabrutinib), a novel oral, reversible Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of patients with warm autoimmune hemolytic anemia (wAIHA), a rare autoimmune disorder marked by the destruction of red blood cells. The Japanese Ministry of Health, Labour and Welfare has also provided rilzabrutinib an orphan designation for the same condition.","length":491,"tagName":"p"},{"type":"text","content":"Both designations are based on clinical data from the ongoing LUMINA 2 phase 2b study (clinical study identifier: NCT05002777) assessing the efficacy and safety of rilzabrutinib for patients with wAIHA. In addition, the new LUMINA 3 phase 3 study (clinical study identifier: NCT07086976), is assessing rilzabrutinib ...