Amgen, UCB Get CHMP Positive Opinion for Evenity
18 October 2019 - 10:04PM
Dow Jones News
By Colin Kellaher
Amgen Inc. (AMGN) and UCB S.A. (UCB.BT) on Friday said the
European Medicines Agency's Committee for Medicinal Products for
Human Use recommended approval of the bone builder Evenity for
severe osteoporosis in postmenopausal women at high risk of
fracture and with no history of myocardial infarction or
stroke.
The European Commission, which generally follows the CHMP's
recommendations, is expected to make a final decision by the end of
the year, the biopharmaceutical companies said.
The CHMP earlier this year recommended against approval of
Evenity, but Amgen and UCB requested a re-examination.
The U.S. Food and Drug Administration approved Evenity in April,
with the drug carrying a warning on its labeling stating that it
could increase the risk of heart attack, stroke and cardiovascular
death and shouldn't be used by patients who have suffered a heart
attack or stroke within the last year.
Amgen, based in Thousand Oaks, Calif., and Belgium's UCB
developed Evenity under a collaboration and license agreement they
formed in 2004.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 18, 2019 06:49 ET (10:49 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
Amgen (NASDAQ:AMGN)
Historical Stock Chart
From Apr 2024 to May 2024
Amgen (NASDAQ:AMGN)
Historical Stock Chart
From May 2023 to May 2024