Osteoporosis drug licensed for women with high fracture risk

Amgen on June 1 announced the licensing of denosumab injection for use in postmenopausal women who have osteoporosis and are at high risk for fracture. The FDA-approved labeling for the drug, which will be sold as Prolia, defines a high risk for fracture as a history of osteoporotic fracture. Other indications are the treatment of postmenopausal women with multiple risk factors for fracture or intolerance or lack of response to other osteoporosis treatments. The product should be administered once every six months, according to the labeling. Denosumab is a human IgG2 monoclonal antibody specific for the receptor activator of nuclear factor kappa-B ligand, or RANKL. The antibody inhibits RANKL-mediated osteoclast formation, resulting in decreased bone resorption. In a placebo-controlled clinical trial involving 7808 women, twice-yearly injection of denosumab 60 mg was associated with a 68% reduction in vertebral fractures, a 20% decrease in nonvertebral fractures, and a 40% decrease in hip fractures, according to Amgen.