The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of Wayrilz as a new treatment for immune thrombocytopenia in adult patients who are refractory to other treatments. A final decision is expected in the coming months. The positive CHMP opinion is based on the pivotal LUNA 3 phase 3 study, presented at the 66th American Society of Hematology Annual Meeting and Exposition in December 2024 and also published in Blood. Wayrilz met both the primary and secondary endpoints, making LUNA 3 the first phase 3 study to show a positive impact on sustained platelet counts, bleeding, and other ITP symptoms with an oral, reversible, Bruton’s tyrosine kinase inhibitor.
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