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FDA approves Mulpleta for thrombocytopenia in adults with chronic liver disease
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The FDA approved lusutrombopag for the treatment of thrombocytopenia among adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.
The FDA based the approval of lusutrombopag (Mulpleta, Shionogi) on two randomized, double-blind trials that included 312 patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure. All patients had a platelet count of less than 50 x 109/L.
Researchers randomly assigned patients 1:1 to received 3 mg of lusutrombopag or placebo once daily for up to 7 days.
In one trial, 78% of patients randomly assigned lusutrombopag required no platelet transfusion prior to the invasive procedure compared with 13% of those randomly assigned placebo (P < .0001). In the second trial, 65% of patients in the treatment arm required no platelet transfusion or rescue therapy for bleeding compared with 29% of the control arm (P < .0001).
The most common adverse reaction was headache.