EMA Panel Backs Lusutrombopag for Thrombocytopenia in Adults With Liver Disease

Megan Brooks

Disclosures

December 14, 2018

The European Medicine Agency's (EMA's) Committee for Medicinal Products for Human Use has approved the thrombopoietin receptor agonist Lusutrombopag Shionogi for the treatment of severe thrombocytopenia in adults with chronic liver disease who are to undergo an invasive procedure.

Lusutrombopag Shionogi reduces the need for platelet transfusions before primary invasive procedures and can be used for rescue therapy in the event of bleeding during the 7 days after such procedures, the EMA said in a statement.

The most common side effects are headache, nausea, portal vein thrombosis, and rash.

The summary of product characteristics, which will be published in the European public assessment report after the European Commission grants marketing authorization, will include detailed recommendations for use of Lusutrombopag Shionogi. That report will be made available in all official European Union languages.

Lusutrombopag Shionogi will be available as 3-mg film-coated tablets.

Last July, the US Food and Drug Administration (FDA) 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, as reported by Medscape Medical News.

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 × 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 of 49) who were treated with lusutrombopag required no platelet transfusion prior to the procedure, compared with 13% of patients (six of 48) who received placebo.

In L-PLUS 2, 65% of patients (70 of 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% of patients (31 of 107) who received placebo.

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