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JULY 31, 2018

FDA Approves Mulpleta for Thrombocytopenia in Adults With Chronic Liver Disease

By PPN News Staff

The FDA approved lusutrombopag (Mulpleta, Shionogi Inc.) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.

Approval was based on two randomized, double-blind, placebo-controlled trials (L-PLUS 1 and L-PLUS 2) involving 312 patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure and had a platelet count less than 50×109/L. Patients were randomly assigned 1:1