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Shionogi seeks US, European approval for low blood platelet count drug

Shionogi & Co. Ltd. said the U.S. Food and Drug Administration and European Medicines Agency accepted its application for S-888711 to treat thrombocytopenia in patients with chronic liver disease who are at increased risk for bleeding from invasive procedures.

Thrombocytopenia is a common complication of chronic liver disease, characterized by low blood platelet count.

The Japanese company's applications are backed by the results of two phase 3 clinical trials where S-888711, or lusutrombopag, met its main goals of not requiring platelet transfusion or rescue therapy from bleeding and increasing platelet count.

Shionogi's new drug application was granted priority review by the FDA, with the target action date set for Aug. 26.