Evenity back with US regulators for approval

UCB and Amgen are seeking permission from US regulators to market Evenity (romosozumab) for the treatment of osteoporosis in postmenopausal women at high risk of fracture.
Evenity is a bone-forming monoclonal antibody which inhibits sclerostin. It both increases bone formation and reduces bone resorption. In the first 12 months of the FRAME trial, women given monthly subcutaneous injections of Evenity cut their risk of a vertebral fracture by 73% compared with those given placebo. The same was true in the second 12 months when the patients were moved onto treatment with denosumab, where the relative risk of a clinical fracture was cut by 36%.
In the ARCH study, postmenopausal women with osteoporosis being treated with Evenity experienced a 48% percent relative reduction in the risk of a new vertebral (spine) fracture versus those given just alendronate, over a 2 year period. Their risk of both non-vertebral fracture and clinical vertebral fracture was also reduced by 27%.
Sean Harper, executive vice president of Research and Development at Amgen, said: “A fracture due to osteoporosis can be a life-altering event, and romosozumab has the potential to reduce fracture risk in patients at high risk due to a prior fracture. We look forward to continuing our work with the FDA to demonstrate the benefit-risk profile for romosozumab. Our hope is to bring to patients an innovative treatment option that addresses a serious unmet medical need.”