EMA/CHMP December 2018 meeting highlights

At its December 2018 meeting, the European Medicines Agency’s the Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for approval.

Two orphan medicines received a positive opinion from the Committee: Besremi (ropeginterferon alfa-2b), from Austrian firm AOP Orphan Pharmaceuticals, for the treatment of polycythemia vera without symptomatic splenomegaly, and Trecondi (treosulfan), from Germany’s medic Gesellschaft, for the conditioning treatment prior to allogeneic haematopoietic stem cell transplantation.

There were two positive opinions for Japan’s Shionogi (TYO: 4507). The CHMP recommended granting a marketing authorization for Lusutrombopag Shionogi (lusutrombopag), for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures, and Rizmoic (naldemedine) for the treatment of opioid-induced constipation.