CHMP recommends approval of Lusutrombopag Shionogi for thrombocytopenia.- Shionogi.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Lusutrombopag Shionogi (lusutrombopag), from Shionogi, intended for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures.

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.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. The full indication is: "treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures."