EU approves Mulpleta for severe thrombocytopaenia.- Shionogi

The European Commission (EC) has granted marketing approval for Mulpleta (lusutrombopag), from Shionogi, for the treatment of severe thrombocytopaenia in adults with chronic liver disease, who are undergoing invasive procedures. The approval is based on two pivotal Phase III randomised clinical trials, L-PLUS1 and L-PLUS2, in which the treatment meant that the patients needed no platelet transfusion prior to the primary invasive procedure, or rescue therapy for bleeding within seven days post-procedure. The benefit of Lusutrombopag Shionogi is that it reduces the need for platelet transfusions before the primary invasive procedure and for rescue therapy for bleeding during the 7 days after the procedure. The most common side effects are headache, nausea, portal vein thrombosis and rash.

Comment: Lusutrombopag Shionogi will be available as 3 mgfilm-coated tablets. Lusutrombopag is a thrombopoietin(TPO) receptor agonist which acts on the transmembrane domain of TPO receptors, to induce proliferation and differentiation of megakaryocyte progenitor cells, thus leading to thrombocytopoiesis.