(RTTNews) - Amgen (AMGN) and UCB said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has adopted a positive opinion recommending Marketing Authorization for EVENITY or romosozumab for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke.
EVENITY is a novel bone-builder with a dual effect that increases bone formation and to a lesser extent reduces bone resorption or bone loss.
The European Commission, which has the authority to approve medicines for use throughout the European Union, will review the CHMP's recommendation. A European Commission decision is expected by year-end 2019.
EVENITY is approved in U.S. for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
EVENITY is also approved in Japan and South Korea for the treatment of osteoporosis for women and men at high risk for fracture, in Canada for the treatment of osteoporosis for postmenopausal women at high risk for fracture, and in Australia for the treatment of osteoporosis in postmenopausal women at high risk of fracture and as a treatment to increase bone mass in men with osteoporosis at high risk of fracture.
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