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Sanofi's Rilzabrutinib Wayrilz Granted FDA Breakthrough Therapy Designation In The US And Orphan Drug Status In Japan For Treatment Of Warm Autoimmune Hemolytic Anemia

Benzinga·02/09/2026 07:10:33
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  • 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 modulation
  • Rilzabrutinib holds global regulatory designations across multiple rare diseases, underscoring its broad therapeutic potential