Amgen and UCB’s Evenity (romosozumab) has been approved in Europe to treat osteoporosis, marking the first new treatment for the condition in the region for nearly 10 years.
The decision allows physicians to prescribe the drug – which increases bone formation and reduces bone loss – to postmenopausal women with severe osteoporosis at high risk of fracture.
A woman is five times more likely to suffer another fracture within a year of a first fracture, potentially impacting quality of life and independence.
“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, executive vice president of Research and Development at Amgen.
"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," 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."
The first launches of Evenity in the European Economic Area (EEA) are planned for first half of 2020, the firms noted.