Sanofi (SNY) announced that the Ministry of Health, Labour, and Welfare (MHLW) in Japan has granted marketing and manufacturing approval for Wayrilz in the treatment of persistent or chronic immune thrombocytopenia in adult patients who have had an insufficient response or intolerance to other therapies.
The approval was based on results from the Phase 3 LUNA study, in which Wayrilz met its primary endpoints by demonstrating sustained platelet counts and improvements in other disease-related symptoms.
Immune thrombocytopenia (ITP) is a disease characterized by complex immune dysregulation that results in low platelet counts (<100,000/µL). The condition can result in various bleeding symptoms and increases the risk of thromboembolism, which can lead to intracranial hemorrhage, a life-threatening complication.
Wayrilz, also known as Rilzabrutinib, is an oral, reversible Bruton's tyrosine kinase inhibitor (BTKi). The BTK enzyme is expressed in innate immune cells and mediates multiple immune-driven disease processes and inflammatory pathways.
Japan previously granted Orphan Drug Designation to Wayrilz for ITP, IgG4-related disease (IgG4-RD), and warm autoimmune hemolytic anemia (wAIHA). The drug has been approved for the treatment of adult patients with ITP in the U.S., the European Union, the United Arab Emirates (UAE), the United Kingdom (UK), and Japan.
The Phase 3 LUNA study evaluated the efficacy and safety of Wayrilz versus placebo in 202 patients with persistent or chronic ITP. Patients who achieved a platelet count response at 12 weeks were eligible to continue through the full 24-week double-blind period.
At Week 25, 23% of patients treated with Wayrilz achieved statistically significant durable platelet response compared to the placebo arm. The patients in the Wayrilz arm achieved their first platelet response in a median of 36 days and showed a longer duration of platelet response.
Patients receiving Wayrilz also reported a 10.6-point improvement in the overall quality of life, compared with a 2.3-point increase in the placebo group, as measured by the Immune Thrombocytopenia Patient Assessment Questionnaire.
Notably, Wayrilz is also being studied across other rare diseases, including IgG4-related disease (IgG4-RD), warm autoimmune hemolytic anemia (wAIHA), and sickle cell disease.
SNY closed Monday's trade at $41.78, down 1.42%. In the overnight market, shares are trading at $42.04, up 0.62%.
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