The U.S. Food and Drug Administration (FDA) 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 FDA’s decision was based on a review of data from two randomized, double-blind, placebo-controlled trials, L-PLUS 1 and L-PLUS 2, of lusutrombopag in a total of 312 patients. In each trial, participants were randomly assigned to receive 3 mg of lusutrombopag or placebo once daily for up to seven days prior to undergoing an invasive procedure.
In L-PLUS 1, 78 percent of patients (n=38/49) treated with lusutrombopag required no platelet transfusion prior to the procedure, compared with 13 percent (n=6/48) of placebo-treated patients. In L-PLUS 2, 65 percent of lusutrombopag-treated patients (n=70/108) and 29 percent of placebo-treated patients (n=31/107) were transfusion-independent prior to the procedure through seven days after the procedure.
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.