Key Takeaways EMA grants orphan drug designation to Sanofi's rilzabrutinib for IgG4-related disease.Phase II trial shows rilzabrutinib cuts flares, markers and steroid use over 52 weeks.Rilzabrutinib faces FDA ITP decision by Aug. 29, 2025, with EU and China reviews ongoing.Sanofi (SNY) announced that the European Medicines Agency (EMA) has granted orphan drug designation to its investigational BTK inhibitor, rilzabrutinib, for treating IgG4-related disease (IgG4-RD).IgG4-RD is a chronic, immune-mediated ra ...