FDA approves Mulpleta to treat thrombocytopenia in adult patients with chronic liver disease.- Shionogi.

Shionogi & Co., Ltd. announced that, after completing a Priority Review, the FDA has approved Mulpleta (lusutrombopag), a once-daily, orally administered, small molecule thrombopoietin (TPO) receptor agonist for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.

The FDA approval was based on consistent safety and efficacy data from two Phase III clinical trials, L-PLUS 1 and L-PLUS 2, in which Mulpleta met primary and secondary endpoints with statistically significant results. �Therapeutic options in this area are critically needed, as adult patients with chronic liver disease often require multiple procedures for various medical reasons,� said Dr. Nezam Afdhal, Senior Physician in Hepatology at Beth Israel Deaconess Medical Center and Professor of Medicine at Harvard Medical School. �I look forward to being able to offer this new oral treatment to patients, instead of relying solely on platelet transfusion.�