GSK Gets Positive Opinion for Blood Cancer Drug From EU Regulator
2023年11月13日 - 4:49PM
Dow Jones News
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 christian.moess@wsj.com
(END) Dow Jones Newswires
November 13, 2023 02:34 ET (07:34 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
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