NDA for Tavalisse accepted for FDA review

The US Food and Drug Administration has filed Rigel Pharmaceuticals’ (Nasdaq: RIGL) New Drug Application (NDA) for the use of Tavalisse (fostamatinib disodium) in patients with chronic or persistent immune thrombocytopenia (ITP).

California-based biotech firm Rigel expects the action date for the FDA to complete its review will be April 17, 2018, under the Prescription Drug User Fee Act (PDUFA). The FDA previously granted Orphan Drug designation to Tavalisse for the treatment of patients with ITP.

Analysts have forecast peak sales of $360 million if the drug is approved. Rigel’s shares were up 6.6% at $2.66 in mid-morning trading today, having hit $2.71 at market opening.