Fostamatinib tablets for ITPJuly 16, 2018
Fostamatinib disodium hexahydrate (Tavalisse) has been granted approval by US FDA for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP).
Fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, works by targeting the underlying autoimmune cause of the disease by blocking platelet destruction. Its major metabolite, R406, inhibits signal transduction of Fc-activating receptors and B-cell receptor, and ultimately reduces antibody-mediated destruction of platelets.
The approval was based on data from two Phase 3 trials, an open-label extension study, and an initial proof of concept study. Efficacy was evaluated in 163 patients with ITP and safety was evaluated in more than 4,600 patients across other indications for which fostamatinib is being studied.