Sanofi's Wayrilz approved in EU for immune thrombocytopenia
The European Commission has approved Sanofi's Wayrilz (rilzabrutinib) as a new treatment for immune thrombocytopenia (ITP) in adult patients refractory to other therapies.
Paris – Sanofi announced that the European Commission has approved Wayrilz (rilzabrutinib), an oral, reversible Bruton's tyrosine kinase (BTK) inhibitor, for the treatment of adult patients with immune thrombocytopenia (ITP) who are refractory to other treatments.
The approval follows a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). Wayrilz targets the underlying causes of ITP through multi-immune modulation.
ITP is a rare autoimmune disease characterized by low platelet counts, leading to bleeding and reduced quality of life. Sanofi stated that Wayrilz offers a novel approach by targeting the disease's root causes through modulation of multiple immune pathways.
The European approval is based on the LUNA 3 Phase 3 study, which met its primary and secondary endpoints. The study demonstrated sustained platelet response and improvements in other ITP symptoms. Patients receiving Wayrilz reported better quality of life compared to placebo.
Sanofi highlighted that this approval reinforces the company's commitment to developing new treatments for patients living with rare and inflammatory diseases.