Shots:

• The approval is based on three FIT studies results assessing Tavalisse (100/150mg- bid) vs Placebo in 150 patients with chronic ITP in ratio 2:1
• The FIT studies result: FIT-1 (NCT02076399) stable platelets response (SPR) (18% vs 0%); FIT-2 (NCT02076412) SPR (16% vs 4%); FIT-3 (23%)
• Tavalisse (fostamatinib disodium hexahydrate- PO) is a spleen tyrosine kinase (SYK) inhibitor and has received OD designation in Jan-2018

Ref: Rigel | Image: Glassdoor