FDA OKs lusutrombopag for thrombocytopenia in adults with liver disease

FDA has approved lusutrombopag (Mulpleta—Shionogi Inc.) for the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.

FDA has approved lusutrombopag (Mulpleta—Shionogi Inc.) for the treatment of thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. FDA reviewed data from two randomized, double-blind, placebo-controlled trials (L-PLUS 1 and L-PLUS 2), which involved 312 patients with chronic liver disease and severe thrombocytopenia. Patients were randomly assigned to receive 3 mg of lusutrombopag or placebo once daily for up to 7 days. In L-PLUS 1, 78% of patients treated with lusutrombopag required no platelet transfusion prior to the procedure, compared with 13% who received placebo. Lusutrombopag, which had fast track and priority review status, should be initiated 8–14 days before a scheduled procedure.