Romosozumab/CDP7851 for the treatment of osteoporosis

Osteoporosis is an important worldwide health problem, conferring significant costs on healthcare. Current osteoporosis therapies are anti-resorptive and have proven anti-fracture efficacy, while there is a paucity of osteoanabolic therapies. Romosozumab is a humanized monoclonal antibody against sclerostin, an inhibitor of osteoblastic activity. Two-year follow-up data from initial clinical studies show rapid and robust increases in bone mineral density at all sites, except the wrist. Significant increases in bone formation markers have also been observed after administration of romosozumab. Notably, and unprecedented among any currently available therapy, this increase in bone formation is accompanied with control of bone resorption, allowing an enhanced anabolic potential compared with the only other currently available anabolic therapy, teriparatide. Romosozumab has been well tolerated in initial studies and its effects on BMD are augmented by follow-on anti-resorptive therapy. Ongoing Phase III studies will provide data regarding anti-fracture efficacy and comparisons with alendronate, as well as longer-term safety.