Sanofi's Rilzabrutinib Granted Orphan Drug Status In EU For IgG4-Related Disease

(RTTNews) - Sanofi SA (SAN.PA, SNYNF, SNY) announced that 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 is currently under regulatory review in the US, the EU, and China for its potential use in immune thrombocytopenia or ITP. The target action date for the US FDA regulatory decision for immune thrombocytopenia, which was granted fast track designation, is August 29, 2025.

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