FDA approves lusutrombopag for thrombocytopenia

The US Food and Drug Administration approved Mulpleta (lusutrombopag) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.

The New Drug Application (NDA) for lusutrombopag (S-888711) was accepted for filing in February this year, as was the marketing application to the European Medicines Agency. Lusutrombopag was approved by the Ministry of Health, Labor and Welfare in Japan in September 2015.

The approval, granted to Japan’s Shionogi (TYO: 4507), was based on two randomized, double-blind, placebo-controlled trials (L-PLUS 1 and L-PLUS 2, NCT02389621) involving 312 patients with chronic liver disease and severe thrombocytopenia who were undergoing an invasive procedure and had a platelet count less than 50 x 109/L. Patients were randomized 1:1 to receive 3mg of lusutrombopag or placebo once daily for up to 7 days.