EVENITY® (Romosozumab) Receives Positive CHMP Opinion For The Treatment Of Severe Osteoporosis In Postmenopausal Women At High Risk Of Fracture

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[{"type":"text","content":"THOUSAND OAKS, Calif. and BRUSSELS, Oct. 17, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that following a re-examination procedure, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Marketing Authorization for EVENITY® (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).\n\"After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year,1 and these fractures can be life-changing,\" said David M. Reese, M.D., executive vice president of Research and Development at Amgen. \"We are pleased by the Committee's opinion because we believe EVENITY is an important therapeutic development for osteoporosis, and we look forward to the European Commission's decision later this year.\"\nThe CHMP's recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use throughout the European Union. A European Commission decision is expected by year-end 2019. \n\"Post-menopausal osteoporosis and fragility fractures are significant women's health issues that are far too often overlooked, with evidence suggesting that an estimated 77 percent of women aged 67 or older remain undiagnosed and untreated in the first 6 months after a fracture.2 This is why new treatment options are so important,\" said Dr. Pascale Richetta, head of bone and executive vice president, UCB. \"We believe that the Committee's positive opinion is an important step forward to help improve the lives of postmenopausal women with severe osteoporosis who are at high risk of fragility fractures.\"\nEVENITY is approved in U.S. for the treatment of osteoporosis in postmenopausal women at high risk for fracture.3 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 postmenopau...

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