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Sanofi’s Rilzabrutinib Secures the EMA’s Orphan Drug Designation to Treat IgG4-Related Disease

Shots:

  • The EMA has granted ODD to rilzabrutinib for the treatment of IgG4-related disease (IgG4-RD)
  • Rilzabrutinib (PO) is being evaluated in a P-II trial for IgG4-RD with glucocorticoids vs glucocorticoids alone, showing reduced flares, improved disease markers, & steroid sparing over 52 weeks; data presented at EULAR 2025
  • Rilzabrutinib, a reversible covalent BTK inhibitor, is under the review in the US, EU & China for immune thrombocytopenia (ITP), with the US FDA’s target action date of Aug 29, 2025

Ref: Sanofi | Image: Sanofi | Press Release

Related News:- Sanofi Enters a ~$395M Asset Purchase Agreement with Visirna Therapeutics (Arrowhead) for Plozasiran in Greater China

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