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Amgen announced the publication of results from two pivotal phase III studies investigating the safety and effectiveness of denosumab at reducing fracture risk in more than 7,800 women with postmenopausal osteoporosis and in more than 1,400 men with non-metastatic prostate cancer undergoing androgen deprivation therapy (ADT) leading to bone loss. In both studies, published in The New England Journal of Medicine (NEJM), patients receiving twice-yearly denosumab experienced significant increases in bone mineral density (BMD) compared with placebo. The increased BMD was associated with more than a 60% reduction in vertebral fracture in both patientpopulations.
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts, the cells that break down bone. “The discovery of the RANK Ligand pathway represents a significant advance in the understanding of bone biology,” said Roland Baron, Professor and Chair of Department of Oral Medicine, Infection, and Immunity at the Harvard School of Dental Medicine.
“These results demonstrate that targeting the RANK Ligand pathway with denosumab could represent a promising new approach in two different disease settings characterised by bone loss.