European Commission Approves EVENITY® (Romosozumab) for the Treatment of Severe Osteoporosis in Postmenopausal Women at High Risk of Fracture


• First new osteoporosis medicine approved in the European Union (EU) since 2010 • Novel bone-builder with a dual effect that both increases bone formation and reduces bone loss

Brussels, Belgium and Thousand Oaks, Calif (December 12, 2019) – UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) 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. Romosozumab is a novel bone-builder with a dual effect that increases bone formation and to a lesser extent reduces bone resorption (or bone loss).

“Today’s European population is living longer and expecting more out of life in their later years. Yet fragility fractures, due to osteoporosis, affect 1 in 3 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 life,” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “With today’s approval of romosozumab we can now offer patients and clinicians a new medicine that can help drive positive changes in secondary fracture prevention.”

The 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 romosozumab in the European Economic Area (EEA) are planned for the first half of 2020.

As 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 the EU6 nations of France, Germany, Italy, Spain, Sweden, and the UK. This annual expenditure is predicted to increase to over €47 billion by 2030.

“After her first fracture, a woman is five times more likely to suffer another fracture within a year. Romosozumab 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.”

“Fragility fractures can often be avoided but their prevention and management are being neglected despite a large personal, societal and economic impact. With the number of worldwide fractures expected to rise there is a growing need to take action and prioritise post-fracture care through better education, specialist services, lifestyles and medicines,” said Alison Doyle, head of clinical operations for the Royal Osteoporosis Society. “Therefore, we welcome this approval as it represents a new therapeutic option for both patients and health care professionals in addressing this neglected condition.”

European Commission marketing authorization approval is valid in all European Union (EU) and EEA-European Free Trade Association (EFTA) states (Norway, Iceland, and Liechtenstein). Romosozumab is now approved in 37 countries, including the U.S., Japan, Canada and Australia.

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