European Commission Approves EVENITY® (romosozumab) 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, Dec. 11, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced that the European Commission (EC) has granted marketing authorization for EVENITY® (romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture. 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 her first fracture, a woman is five times more likely to suffer another fracture within a year.1 EVENITY is a significant step forward in the management of osteoporosis for physicians who need to treat patients with a medicine that can rapidly increase bone mineral density within 12 months,\" said David M. Reese, M.D., executive vice president of Research and Development at Amgen. \"We are pleased by the European Commission's approval to make this therapy available to the millions of women at high risk of fracture in the European Union.\"\nThe approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) that was received in October 2019. The first launches of EVENITY in the European Economic Area (EEA) are planned for first half of 2020.\nAs the population ages, the incidence and contribution of fragility fractures to the overall healthcare spend in Europe will continue to rise. Recent studies estimate that every year €37 billion is spent on healthcare costs for the 2.7 million fragility fractures that occur across France, Germany, Italy, Spain, Sweden and the UK.2 This annual expenditure is predicted to increase to over €47 billion by 2030.2 \n\"Today's European population is living longer and expecting more out of life in their later years. Yet fragility fractures due to osteoporosis affect one in three women aged over 50, and evidence shows that many women remain undiagnosed and untreated following a fracture. These fractures represent a barrier to healthy aging, potentially impacting independence and quality of life2,\" said Dr. Pascale Richetta, head of bone and executive vice president, UCB. \"With today's approval of EVENITY we can now offer patients and clinicians a new medicine that can help drive positive changes in secondary fracture prevention.\"\n\"Fragility fractures can often be avoided, but their prevention ...

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