Shionogi initiates rolling submission of lusutrombopag NDA

Based on new data, Japanese pharma company Shionogi has initiated rolling submission of a New Drug Application to the US Food and Drug Administration for lusutrombopag as a treatment for thrombocytopenia in patients with chronic liver disease undergoing non-emergent invasive procedures.

Lusutrombopag, a once-daily, orally administered, small molecule thrombopoietin receptor agonist, already had Fast Track Designation from the FDA. It demonstrated superiority to placebo and met the primary and all pre-specified important secondary endpoints in a global Phase III study.