- 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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Wednesday, November 18, 2020
Sanofi rilzabrutinib Fast Track'd in U.S. for low platelet count
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