Amgen, UCB Get CHMP Positive Opinion for Evenity

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 [e-mail]

(END) Dow Jones Newswires

October 18, 2019 06:49 ET (10:49 GMT)

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