Shionogi announced that the Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for lusutrombopag (S-888711) for the treatment of thrombocytopenia in patients with chronic liver disease who are at increased risk for bleeding associated with invasive procedures. The NDA has been granted Priority Review.
The NDA submission was supported by data from the Phase 3 L-PLUS1 and L-PLUS2 trials in which lusutrombopag met the primary and major secondary endpoints with statistically significant results. In L-PLUS2 (N=215), patients were randomized 1:1 to either lusutrombopag 3mg or placebo for up to 7 days. The primary endpoint was the number of patients who required no platelet transfusion priory to primary invasive procedure and no rescue therapy for bleeding for 7 days post-procedure. The data showed 64.8% of the lusutrombopag treatment group met the primary endpoint vs. 29.0% of the placebo group. The lusutrombopag group also showed superiority in the secondary endpoints with 64.8% achieving a platelet count of ≥50,000/µL and an increase of ≥20,000/µL from baseline compared to 13.1% of patients taking placebo.
Lusutrombopag is an investigational, oral, small molecule agonist of the human thrombopoietin receptor. It has previously been granted Fast Track status by the FDA. The Priority Review status shortens the review time from a standard 10-month review to a goal of 6 months. The FDA has set a Prescription Drug User Fee Act (PDUFA) date for a decision by August 26, 2018.
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