Posted by Michael Wonder on 27 Feb 2018
Shionogi announces FDA new drug application and EMA marketing authorisation application acceptances for lusutrombopag (S-888711)
26 February 2018 - Shionogi announced today that the new drug application for lusutrombopag (S-888711), an investigational, once-daily, orally administered, small molecule thrombopoietin receptor agonist, has been accepted for filing and has been granted priority review by the U.S. FDA.
In the United States, Shionogi is seeking FDA approval of lusutrombopag for the treatment of thrombocytopenia in patients with chronic liver disease who are at increased risk for bleeding associated with invasive procedures.
The submission is based on two Phase 3 clinical trials, L-PLUS1 and L-PLUS2, in which lusutrombopag met the pre-specified primary and all key secondary endpoints with statistically significant results. The Prescription Drug User Fee Act date for an FDA decision is 26 August 2018.
