The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for approval, including two orphan medicines at its December 2018 meeting22.
A) The seven medicines recommended for approval are:
Besremi - for the treatment of polycythaemia vera without symptomatic splenomegaly.
On December 13, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Besremi, intended for the treatment of polycythaemia vera without symptomatic splenomegaly. Besremi was designated as an orphan medicinal product on December 09, 2011.
Besremi will be available as a solution for injection (250 microgram/0.5 ml and 500 microgram /0.5 ml). The active substance of Besremi is ropeginterferon alfa-2b, which inhibits the proliferation of hematopoietic and bone marrow fibroblast progenitor cells and antagonises the action of growth factors and other cytokines involved in the development of myelofibrosis.
The applicant for Besremi is AOP Orphan Pharmaceuticals AG23.
2. Lusutrombopag Shionogi - for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures.
On December 13, 2018, 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, intended for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures.
Lusutrombopag Shionogi will be available as 3 mg film-coated tablets. The active substance of Lusutrombopag Shionogi is lusutrombopag, a thrombopoietin (TPO) receptor agonist. Lusutrombopag acts on the transmembrane domain of TPO receptors, to induce proliferation and differentiation of megakaryocyte progenitor cells, thus leading to thrombocytopoiesis.
The applicant for Lusutrombopag is Aeterna Shionogi B.V.24
Download >> European Medicines Agency (EMA): Recommends Approval Of Four Medicines In Its December Meeting
Footnotes
23 https://www.ema.europa.eu/documents/smop-initial/chmp-summary-positive-opinion-besremi_en.pdf
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