FDA OKs Lusutrombopag for Thrombocytopenia in Adults With Liver Disease

Megan Brooks


July 31, 2018

The US Food and Drug Administration (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.

In approving the thrombopoietin receptor agonist, the FDA reviewed data from two randomized, double-blind, placebo-controlled trials (L-PLUS 1 and L-PLUS 2). The trials involved 312 patients with chronic liver disease and severe thrombocytopenia who were to undergo an invasive procedure and whose platelet count was <50 x 109/L. 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 (38/49) treated with lusutrombopag required no platelet transfusion prior to the procedure, compared with 13% (6/48) who received placebo.

In L-PLUS 2, 65% of patients (70/108) who received lusutrombopag required no platelet transfusion prior to the procedure or rescue therapy for bleeding from the time of randomization through 7 days after the procedure, compared with 29% (31/107) who received placebo.

The most common adverse reaction was headache.

According to the prescribing label, lusutrombopag should be initiated 8 to 14 days prior to a scheduled procedure. Patients should undergo their procedure 2 to 8 days after taking the last dose.

The recommended dose is 3 mg taken orally once daily with or without food for 7 days. In the case of a missed dose, patients should take the missed dose as soon as possible on the same day and return to the normal schedule the following day.

Lusutrombopag has been investigated only when used in a single 7‐day once-daily dosing regimen in clinical trials in patients with chronic liver disease. It should not be given to patients with chronic liver disease in an attempt to normalize platelet count. A platelet count should be obtained prior to starting lusutrombopag and not more than 2 days before the procedure. Full prescribing information is available online.

Lusutrombopag had fast track and priority review status.

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