FDA approves Prolia(Amgen) for treatment of Male Osteoporosis

Amgen announced the FDA has approved a new indication for Prolia (denosumab) as a treatment to increase bone mass in men with Osteoporosis at high risk for fracture. Prolia, the first FDA approved RANK Ligand inhibitor, is a subcutaneous injection administered by a health care professional every six months. According to the National Osteoporosis Foundation,two million men in the U.S. have osteoporosis and another 12 million are at risk. Osteoporosis and osteoporotic fractures in men remain under diagnosed and under treated. The new indication for Prolia is based on results from the ADAMO Phase III study involving 242 men with low bone mineral density (BMD). In the study, treatment with Prolia resulted in significantly greater gains at the lumbar spine when compared to placebo (5.7 percent vs. 0.9 percent). Effects of Prolia on BMD were independent of age, baseline testosterone levels, BMD status and estimated fracture risk.