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Sanofi's Rilzabrutinib Gains Regulatory Designations in Japan and U.S. for Rare Diseases

Mar 03, 2026

Sanofi's oral BTK inhibitor rilzabrutinib received orphan drug designation in Japan for IgG4-related disease and warm autoimmune hemolytic anemia, while also securing U.S. FDA breakthrough therapy designation for the rare anemia indication.

Sanofi's Rilzabrutinib Receives Orphan Drug Designation in Japan for IgG4-Related Disease

Mar 02, 2026

Japan's Ministry of Health, Labour and Welfare has granted orphan drug designation to Sanofi's rilzabrutinib for IgG4-related disease, marking the third global orphan designation for this indication based on positive phase 2 study data.