Posted by Michael Wonder on 15 Dec 2018
Highlights from the CHMP 10-13 December 2018 meeting
14 December 2018 - EMA’s CHMP recommended seven medicines for approval at its December 2018 meeting.
Two orphan medicines received a positive opinion from the Committee: Besremi (ropeginterferon alfa-2b), for the treatment of polycythaemia vera without symptomatic splenomegaly, and Trecondi (treosulfan), for the conditioning treatment prior to allogeneic haematopoietic stem cell transplantation.
The CHMP recommended granting a marketing authorisation for Lusutrombopag Shionogi (lusutrombopag), for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures.
Rizmoic (naldemedine) received a positive opinion for the treatment of opioid-induced constipation.
