Sanofi's Platelet Disorder Drug Wayrilz Wins EU Commission Nod

MT Newswires · 2d ago
09:50 AM EST, 12/23/2025 (MT Newswires) -- The European Commission approved Sanofi's (SAN.PA) Wayrilz, or rilzabrutinib, as a new treatment for immune thrombocytopenia, or ITP, a rare disorder characterized by low platelet counts and bleeding. The approval covers the use of Wayrilz in adult patients with ITP who are refractory to other treatments, making it the first Bruton's tyrosine kinase inhibitor approved for the condition, according to a Tuesday release. It is based on results of the phase 3 Luna 3 study, in which patients treated with Wayrilz achieved "rapid and durable" platelet improvements. The French pharmaceutical group's Wayrilz previously received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in October.