Rigel announced its submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for fostamatinib for the treatment of patients with chronic and persistent immune thrombocytopenic purpura (ITP).
The submission was based on results from three Phase 3 studies for fostamatinib in ITP, two of which were randomized placebo-controlled trials (Studies 047 and 048) and one open-label extension study (Study 049). Preclinical data and drug manufacturing data for fostamatinib were also included in the NDA submission. Rigel expects to receive the status of the NDA submission in June 2017.
The FDA previously granted fostamatinib Orphan Drug designation for ITP in 2015. In addition to the ITP indication, the company is also investigating fostamatinib in other autoimmune disorders such as autoimmune hemolytic anemia (AIHA) and IgA nephropathy (IgAN).
Fostamatinib is an oral inhibitor of the spleen tyrosine kinase (SYK), a key player in the immune process that leads to platelet destruction in ITP.
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