Shionogi & Co. announced that 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, is now available throughout the United States.“We are very excited about the launch of Mulpleta in the United States, recently approved as a new, safe and effective treatment,” said Takayuki Yoshioka, president, and CEO, Shionogi Inc. “As adult patients with CLD often undergo procedures that could put them at increased risk for bleeding, this treatment will offer physicians and patients an option other than platelet transfusions. Additionally, we have developed Mulpleta Assist, a support center for physicians and patients, to help make Mulpleta easier to access and ensure that patients receive Mulpleta before their procedure.”
Mulpleta Assist is a full-service patient access and support program that offers healthcare providers and patients a dedicated resource to help manage medication logistics, coordinate managed care reimbursement, matching financial assistance, as well as provide overall patient support. Shionogi is committed to helping patients access and afford Mulpleta and have the support necessary to achieve the full benefit of this therapy.
The U.S. FDA approved Mulpleta on July 31, 2018. 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.