FDA Grants Breakthrough Therapy Designation to Sanofi's Wayrilz for Rare Blood Disorder wAIHA
The US FDA has granted breakthrough therapy designation to Wayrilz (rilzabrutinib) for warm autoimmune haemolytic anaemia, while Japan’s health ministry awarded orphan status, accelerating development for the rare disorder.
Wayrilz | 11/02/2026 | 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.
Wayrilz | 24/12/2025 | By News Bureau
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