FDA OKs Lusutrombopag for Thrombocytopenia in Adults With Liver Disease

"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."

- By Megan Brooks for Medscape.com

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