Japan Grants Orphan Drug Designation to Sanofi's Rilzabrutinib
Sanofi’s rilzabrutinib has received Orphan Drug Designation in Japan for IgG4-related disease (IgG4-RD), supported by positive phase-II study results. The decision marks the therapy’s third global orphan designation in this indication, underscoring Sanofi’s continued focus on advancing treatments for rare immune-mediated diseases.
Rilzabrutinib | 02/03/2026 | By News Bureau
EU Approves Sanofi's Wayrilz as First BTK Inhibitor for Immune Thrombocytopenia
Sanofi has received EU approval for Wayrilz, the first Bruton’s Tyrosine Kinase (BTK) inhibitor indicated for immune thrombocytopenia, offering a novel multi-immune modulation approach. The approval is based on positive results from LUNA 3 study, which demonstrated rapid and durable platelet responses.
Rilzabrutinib | 24/12/2025 | By News Bureau | 117
Effects of rilzabrutinib in individuals with insusceptible thrombocytopenia
Positive phase 1/2 study results of rilzabrutinib in people with immune thrombocytopenia published in The New England Journal of Medicine
Rilzabrutinib | 16/04/2022 | By Sudeep Soparkar | 1081
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