Rilzabrutinib granted FDA fast track designation for treatment of immune thrombocytopenia

Sanofi

18 November 2020 - Phase 3 trial initiated to evaluate rilzabrutinib, the potential first Bruton’s tyrosine kinase inhibitor for the treatment of immune thrombocytopenia.

The U.S. FDA has granted fast track designation to the oral investigational Bruton’s tyrosine kinase (BTK) inhibitor, rilzabrutinib, which has the potential to be the first BTK inhibitor for the treatment of immune thrombocytopenia (ITP). 

In addition, following positive Phase 1/2 study results, a Phase 3 study evaluating rilzabrutinib for ITP has been initiated.

Read Sanofi press release

Michael Wonder

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Michael Wonder

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Medicine , US , Fast track