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Amgen-UCB's Evenity approved in EU to treat bone disorder

The European Commission approved Amgen Inc. and UCB SA's osteoporosis medicine Evenity in postmenopausal women at high risk of fracture.

Osteoporosis is a condition in which the bones become weak and brittle, and are prone to fractures.

The European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, recommended the medicine for approval in October, having originally rejected it in June.

The companies plan to begin the launch of the drug in the European Economic Area in the first half of 2020.

Evenity is approved in the U.S. and Canada for treating osteoporosis in postmenopausal women at high risk for fracture, and in Japan and South Korea for treating osteoporosis in women and men at high risk for fracture.

The drug is approved in the U.S. with a black-box warning — the U.S. Food and Drug Administration's highest risk alert — that cautions patients and prescribers regarding cardiovascular risk.