Press Release: Sanofi’s rilzabrutinib earns orphan designation in the EU for IgG4-related disease

Sanofi's rilzabrutinib earns orphan designation in the EU for IgG4-related disease Paris, August 14, 2025. The European Medicines Agency has granted orphan designation to rilzabrutinib, a reversible covalent Bruton's tyrosine kinase (BTK) inhibitor, for IgG4-related disease (IgG4-RD). EMA grants orphan designation to investigational therapies addressing rare, life-threatening or debilitating medical diseases or conditions that affect no more than 5 in 10,000 persons in the EU. Rilzabrutinib for the treatmen ...