Posted by Michael Wonder on 18 Oct 2025
Sanofi’s Wayrilz recommended for EU approval by the CHMP to treat immune thrombocytopenia
17 October 2025 - Recommendation based on LUNA 3 Phase 3 study demonstrating rapid and durable platelet response and significant improvements in bleeding, quality of life measures, and other immune thrombocytopenia symptoms.
The EMA’s CHMP has adopted a positive opinion recommending the approval of Wayrilz (rilzabrutinib) as a new treatment for immune thrombocytopenia in adult patients who are refractory to other treatments.
