Shionogi & Co., Ltd. announced that, after completing a Priority Review, the U.S. Food and Drug Administration (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.
“We are very pleased the FDA has approved Mulpleta as a new, safe and effective treatment,” said Takayuki Yoshioka, President and Chief Executive Officer, Shionogi Inc. “This new therapy offers physicians and patients another choice beyond platelet transfusions as adult patients with CLD often undergo procedures that could put them at increased risk for bleeding.”
The FDA approval was based on consistent safety and efficacy data from two Phase 3 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.”