Shionogi sought FDA NDA and EMA MAA for lusutrombopag (S-888711)

Shionogi asserted that the 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 U.S. Food & Drug Administration (FDA). 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.

Lusutrombopag (S-888711) is an orally administered, small molecule agonist of the human thrombopoietin receptor. Lusutrombopag was approved by the Ministry of Health, Labor and Welfare in Japan in September 2015 for the improvement of thrombocytopenia associated with CLD in patients undergoing an elective invasive procedure.

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.

John Keller, President and Chief Executive Officer, Shionogi Inc said “We at Shionogi look forward to the upcoming FDA review, and the near future in which patients and physicians have additional, advanced therapeutic options beyond platelet transfusions which are the current standard of care.”

The FDA Priority Review status enhances the review time from a standard 10-month review to a goal of six (6) months from the date of acceptance of filing. A Priority Review designation will direct overall attention and resources to the evaluation of applications that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.