EC Approves Amgen’s New Osteoporosis Biologic

On Dec. 11, 2019 Amgen and Belgium-based biopharmaceutical company UCB announced that the European Commission (EC) has granted marketing authorization for Evenity (romosozumab), a novel biologic for treating severe osteoporosis in postmenopausal women at high risk of fracture. Evenity is bone-builder that has the dual effect of increasing bone formation and, to a lesser extent, reducing bone resorption (or bone loss).

The approval follows an October 2019 positive opinion from the Committee for Medicinal Products for Human Use and is valid in all European Union and European Economic Area (EEA)–European Free Trade Association (EFTA) states (Norway, Iceland, and Liechtenstein). The first launches of the product in the EEA are planned for the first half of 2020. Evenity is now approved in 37 countries, including the United States, Japan, Canada, and Australia.

"[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, MD, executive vice president of Research and Development at Amgen, in a company press release. "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."

"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 life," said Dr. Pascale Richetta, head of bone and executive vice-president, UCB, in the press release. "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."

"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 prioritize post-fracture care through better education, specialist services, lifestyles, and medicines," added Alison Doyle, head of clinical operations for the Royal Osteoporosis Society, in the press release. "Therefore, we welcome this approval as it represents a new, therapeutic option for both patients and health care professionals in addressing this neglected condition."

Source: Amgen