The European Commission has officially granted marketing authorization for Wayrilz (rilzabrutinib), a pioneering oral therapy for adults with immune thrombocytopenia (ITP). This milestone marks the introduction of the first Bruton’s tyrosine kinase (BTK) inhibitor available for this condition in the European market.
Multi-Immune Modulation Mechanism Wayrilz represents a shift in ITP management by targeting the underlying pathology rather than just addressing symptoms.
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Function: As a reversible and selective BTK inhibitor, it modulates B cells and other innate immune cells involved in the autoimmune response.
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Efficiency: This approach helps prevent the premature destruction of platelets and dampens the chronic inflammatory pathways driving the disease.
Clinical Evidence from the LUNA 3 Study The European approval was supported by data from the pivotal Phase 3 LUNA 3 trial (NCT04562766):
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Sustained Response: 64% of participants treated with Wayrilz achieved a platelet response during the first 12 weeks, doubling the success rate of the placebo group (32%).
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Quality of Life: Patients reported significant relief in fatigue and physical well-being, showing a 10.6-point improvement on specialized assessment scales compared to 2.3 points for the control group.
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Safety Profile: Most common adverse events included mild-to-moderate gastrointestinal symptoms and headaches.
Global Regulatory Status Prior to its European debut, Wayrilz received approvals in the United States and the United Arab Emirates. Regulatory reviews are currently underway in Japan and China. Sanofi is also investigating the drug’s potential for other rare conditions, including warm autoimmune hemo