FDA Approves New Immune Thrombocytopenia Treatment

The FDA has approved Tavalisse (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) with insufficient response to previous treatment.

Tavalisse is an oral spleen tyrosine kinase inhibitor that works by impeding platelet destruction. 
____________________________________________________________________________________

RELATED CONTENT
What Factors Raise Splenectomy Risk in Immune Thrombocytopenia?
How Can You Explain This Patient’s Thrombocytopenia During Hemodialysis?
____________________________________________________________________________________

The approval was based upon the results of the FIT clinical program, including 2 randomized placebo-controlled Phase 3 trials and an open-label extension, as well as an initial proof of concept study.

Common adverse reactions included diarrhea, hypertension, nausea, dizziness, ALT and AST increase, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

—Michael Potts

Reference:

Rigel announces FDA approval of TAVALISSE™ (fostamatinib disodium hexahydrate) for chronic immune thrombocytopenia (ITP) in adult patients [press release]. April 17, 2018. http://ir.rigel.com/phoenix.zhtml?c=120936&p=irol-newsArticle&ID=2343080.