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# Sanofi’s Rilzabrutinib Gets Orphan Drug Designation
- URL: https://www.fdaweb.com/sanofis-rilzabrutinib-gets-orphan-drug-designation/
- Published: 2025-04-03T12:00:00.000Z
- Updated: 2026-09-14T14:56:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158949

FDA has granted orphan drug designation for Sanofi’s rilzabrutinib for two rare diseases — warm autoimmune hemolytic anemia and IgG4-related disease. A company [statement](https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-03-05-00-00-3054815?ref=fdaweb.com) says there is a significant unmet need for the two diseases which do not have any approved medicine.

Rilzabrutinib is described as an investigational, novel, advanced, oral, reversible Bruton’s tyrosine kinase inhibitor that Sanofi says has the potential to be a first- and best-in-class treatment of several immune-mediated diseases. FDA is reviewing it for potential use in immune thrombocytopenia.