Blood
GSK Gets Positive Opinion for Blood Cancer Drug From EU Regulator
Nov
By Christian Moess Laursen
GSK said it has received a positive opinion recommending the approval of its blood-cancer treatment momelotinib from the European Medicines Agency.
The British pharmaceutical giant said the decision on marketing authorization in the EU is expected by early 2024.
The positive opinion was adopted by the Committee for Medicinal Products for Human Use–or CHMP–of the European Medicines Agency, and is one of the final steps prior to marketing authorization decision by the European Commission.
If approved, momelotinib would be the only medicine in the EU specifically for both newly diagnosed and previously treated patients with myelofibrosis–a rare type of blood cancer–and moderate to severe anaemia, that addresses enlarged spleen and symptoms.
Write to Christian Moess Laursen at [email protected]
