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Wednesday, November 18, 2020

Sanofi rilzabrutinib Fast Track'd in U.S. for low platelet count

  • FDA has granted Fast Track Designation to Sanofi's (NASDAQ:SNY) oral investigational Bruton’s tyrosine kinase inhibitor, rilzabrutinib, for the treatment of immune thrombocytopenia (low blood platelets).
  • Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
  • In addition, following positive Phase 1/2 study results, a Phase 3 study evaluating rilzabrutinib for ITP has been initiated.
  • https://seekingalpha.com/news/3637353-sanofis-rilzabrutinib-fast-trackd-in-u-s-for-low-platelet-count

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