Japan Approves Sanofi’s Wayrilz for Chronic Immune Thrombocytopenia Treatment | iPharmaCenter
- Badari Andukuri
- Jun 23
- 2 min read
Sanofi has received approval in Japan for Wayrilz (rilzabrutinib) to treat adults with persistent or chronic immune thrombocytopenia (ITP), particularly in patients who have shown inadequate response or intolerance to prior therapies.
Japan’s Ministry of Health, Labour and Welfare granted the authorization, introducing a new oral treatment that targets immune system dysfunction underlying the disease. Wayrilz is a Bruton’s tyrosine kinase inhibitor designed to act across multiple immune pathways, offering a broader approach to disease control.
Immune thrombocytopenia is a rare autoimmune disorder marked by reduced platelet counts due to increased destruction and impaired production. This can result in bleeding complications and significantly affect patients’ quality of life.
What is the effiacy of Wayrilz in immune thrombocytopenia?
The approval is supported by findings from the phase 3 LUNA 3 study, which enrolled 202 adult patients with persistent or chronic ITP. The trial demonstrated that rilzabrutinib achieved both primary and secondary endpoints, showing clinically meaningful improvements compared to placebo.
At week 25, 23 percent of patients treated with Wayrilz achieved a durable platelet response, while no patients in the placebo group reached this outcome, with strong statistical significance.
Patients receiving the therapy also experienced a faster onset of response, with a median time of 36 days, whereas a comparable response was not observed in the placebo arm.
In addition, the duration of platelet response was notably longer, averaging 7 weeks in the Wayrilz group compared to 0.7 weeks among placebo-treated patients.
Patient-reported outcomes also indicated improvements in quality of life. Individuals treated with Wayrilz reported greater gains in symptom-related measures compared with those receiving placebo, based on a validated ITP-specific assessment tool.
How Rilzabrutinib works and what is it mechanism of action?
Rilzabrutinib works by selectively inhibiting Bruton’s tyrosine kinase, an enzyme involved in B-cell signaling and broader immune responses, including macrophage activity. By modulating these pathways, the therapy aims to address the root immune imbalance driving platelet destruction.
Where is Wayrilz approved?
Wayrilz is already approved in multiple global markets, including the United States, European Union, United Kingdom, and the United Arab Emirates. With this latest decision, Japan expands access to a new treatment option for patients with difficult-to-manage ITP.
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