Sanofi: Wayrilz Approved in Japan for Immune Thrombocytopenia
Sanofi announced on Tuesday that Wayrilz (rilzabrutinib) has been approved by the Japanese Ministry of Health for the treatment of persistent or chronic immune thrombocytopenia in patients who are refractory to other therapies. This new Bruton's tyrosine kinase inhibitor works through multi-targeted immune modulation and is based on the results of the phase 3 LUNA 3 study.
A Drug Targeting the Underlying Mechanisms of the Disease
Wayrilz is a reversible oral Bruton's tyrosine kinase inhibitor (BTKi) designed to act through multi-targeted immune modulation, addressing key pathways involved in immune dysregulation. Immune thrombocytopenia (ITP) is a rare disease characterized by complex immune dysregulation leading to reduced platelet counts, bleeding, and impaired quality of life. The Japanese approval specifically targets patients with persistent or chronic forms who do not sufficiently respond to other treatments or for whom tolerance is an issue.
Efficacy Results from the LUNA 3 Study
The approval is based on the phase 3 LUNA 3 study, which assessed the efficacy and safety of Wayrilz versus placebo in 202 adults with persistent or chronic ITP. The study met its primary and secondary endpoints. According to the release, 64% of patients in the Wayrilz group achieved a platelet response at 12 weeks, compared to 32% in the placebo group. At week 25, 23% of patients receiving Wayrilz maintained a durable platelet response, compared to 0% in the placebo group.
