The U.S. Food and Drug Administration has approved lusutrombopag for the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.
The agency approved the thrombopoietin receptor agonist after reviewing data from 312 patients enrolled in two randomized, double-blind, placebo-controlled trials, L-PLUS 1 and L-PLUS 2. In each trial, participants were randomly assigned to receive lusutrombopag 3 mg or placebo once daily for up to seven days prior to undergoing an invasive procedure.
In L-PLUS 1, 38 of 49 patients (78%) treated with lusutrombopag required no platelet transfusion prior to the procedure, compared with 6 of 48 placebo-treated patients (13%; p<0.0001). In L-PLUS 2, 70 of 108 lusutrombopag-treated patients (65%) and 31 of 107 placebo-treated patients (29%) were transfusion-independent prior to the procedure through seven days after the procedure (p=0.0001).
The most common adverse event associated with lusutrombopag was headache. The prescribing information indicates that lusutrombopag should not be given to patients with chronic liver disease to normalize platelet count, and a platelet count should be obtained prior to starting lusutrombopag.
Source: FDA news release, July 31, 2018.