Days after wielding the ax, Unum hit with clinical hold, again
Shionogi`s Lusutrombopag Receives Approval in Europe
The European Commission (EC) has granted marketing approval for Shionogi’s lusutrombopag, for the treatment of severe thrombocytopaenia in adults with chronic liver disease (CLD), who are undergoing invasive procedures.
Committee for Orphan Medicinal Products (COMP) meeting report on the review of applications for orphan designation
Two orphan medicines1 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 therapy is lusutrombopag (Mulpleta), which handily beat the August 26 PDUFA date that the FDA had handed Shionogi when it accepted the drug for a priority review schedule back in February.