Sanofi: fast track designation procedure for rilzabrutinib
(CercleFinance.com) - Sanofi has announced that the US FDA has granted a fast track designation procedure to rilzabrutinib, the potential first BTK inhibitor (Bruton's tyrosine kinase inhibitor), to be taken orally, for the treatment of immune thrombocytopenia
This autoimmune disorder is characterised by decreased platelet survival and disruption of platelet production leading to thrombocytopenia, a predisposition to bleeding and deterioration in patients' quality of life.
The positive results from a Phase I/II study have also prompted the initiation of a Phase III study to evaluate rilzabrutinib, for which the FDA already granted orphan drug status in October 2018.
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