Amgen and UCB have announced the US Food and Drug Administration (FDA) approval of Evenity (romosozumab) for osteoporosis in postmenopausal women at high risk for fracture.
The drug is the first and only bone builder with a unique dual effect that both increases bone formation and to a lesser extent reduces bone resorption to rapidly reduce the risk of fracture.
The approval is based on the results of two Phase III studies, which showed a significant reduction of new vertebral (spine) fracture at 12 months compared to placebo. The significant reduction in fracture risk persisted through the second year in women who received the treatment during the first year and transitioned to denosumab, compared to those who transitioned from placebo to denosumab.
The drug also significantly increased bone mineral density (BMD) at the lumbar spine, total hip and femoral neck compared to placebo at 12 months.
"Fractures can be devastating, with many leading to hospital stays and life-altering consequences. The FDA approval of Evenity represents an important therapeutic development for patients who need a medicine that can rapidly increase bone mineral density and help reduce the risk of future fractures within 12 months," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
"Postmenopausal osteoporosis is a significant women's health issue that far too often gets overlooked. As a leader in bone health with more than 20 years of osteoporosis research experience, Amgen is as committed as ever to combatting this disease to help women at high risk for fracture reduce their risk of a first and subsequent fracture."
One in two women will experience a fracture due to osteoporosis in their lifetime. According to the World Health Organisation (WHO), the disease is a major public health crisis, affecting millions of people worldwide.