Shionogi announced that Mulpleta (lusutrombopag) is now available for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.
Mulpleta is a once-daily, oral, small molecule thrombopoietin (TPO) receptor agonist. It is designed to interact with the transmembrane domain of human TPO receptors to induce the proliferation and differentiation of megakaryocytic progenitor cells from hematopoietic stem cells and megakaryocyte maturation.
The Food and Drug Administration (FDA) initially approved Mulpleta on July 31, 2018, based on consistent safety and efficacy data from two Phase 3 clinical trials (L-PLUS 1 and L-PLUS 2). The primary efficacy outcome in L-PLUS 1 was the proportion of patients who required no platelet transfusion prior to the primary invasive procedure, In L-PLUS 2, the major efficacy outcome was the proportion of patients who require no platelet transfusion prior to the primary invasive procedure and no rescue therapy for bleeding (i.e., platelet preparations, other blood preparations, including red blood cells and plasma, volume expanders) from randomization through 7 days after the primary invasive procedure.
Both primary outcomes were met with statistically significant data.
Mulpleta is supplied in 3mg strength tablets in blister packs containing 7 tablets.
For more information call (800) 849-9707 or visit Mulpleta.com.