EMA approves new haematological therapies


  • Dawn O'Shea
  • Univadis Medical News
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The European Medicines Agency (EMA) has approved Lusutrombopag Shionogi (lusutrombopag) for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures.

Lusutrombopag acts on the transmembrane domain of thrombopoietin (TPO) receptors to induce proliferation and differentiation of megakaryocyte progenitor cells, leading to thrombocytopoiesis. It has been shown to reduce the need for transfusions before invasive procedure and rescue therapy for bleeding during the seven days after the procedure.

The EMA has also adopted a positive opinion on granting full marketing authorisation to Besremi (ropeginterferon alfa-2b) for the treatment of polycythaemia vera without symptomatic splenomegaly.

Besremi was designated as an orphan medicinal product on 9 December 2011. Ropeginterferon alfa-2b inhibits proliferation of haematopoietic and bone marrow fibroblast progenitor cells and antagonises the action of growth factors and other cytokines involved in the development of myelofibrosis. It has been shown to achieve complete haematological responses in patients with polycythaemia vera.

Detailed recommendations for the use of these products will be described in the summary of product characteristics (SmPC), which will be published after marketing authorisation has been granted by the European Commission.