Sanofi announces European Commission approval of Wayrilz

The European Commission has approved Wayrilz, a novel, oral, reversible, Bruton’s tyrosine kinase inhibitor, as a new treatment for immune thrombocytopenia in adult patients who are refractory to other treatments. This follows the positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use. Wayrilz can help address the underlying causes of ITP through multi-immune modulation, targeting different pathways across the immune system. The EU approval of Wayrilz is based on the pivotal LUNA 3 phase 3 study, in which Wayrilz met the primary and secondary endpoints, demonstrating a positive impact on sustained platelet counts as well as other ITP symptoms.