US and European filings for lusutrombopag accepted by regulators

The New Drug Application (NDA) for lusutrombopag (S-888711), an investigational, once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist, has been accepted for filing and has been granted Priority Review by the US Food and Drug Administration, says Japanese drug major Shionogi (TYO: 4507).

In the USA, 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 III 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 (PDUFA) date for an FDA decision is August 26, 2018.