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Sanofi: Rilzabrutinib Granted Fast Track Designation - Quick Facts

Sanofi (SNYNF,SNY) said the U.S. FDA has granted Fast Track Designation to the oral investigational Bruton's tyrosine kinase inhibitor, rilzabrutinib for the treatment of immune thrombocytopenia. The company noted that a phase 3 study evaluating rilzabrutinib for ITP has been initiated. Rilzabrutinib received orphan drug designation for the treatment of immune thrombocytopenia in October 2018.

Rilzabrutinib is an oral, reversible covalent, Bruton's tyrosine kinase inhibitor being investigated for the treatment of immune mediated diseases. It is being investigated in a phase 3 trial for pemphigus.

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