FDA expands approval of Amgen's Prolia to males with osteoporosis

The FDA expanded approval of Amgen's Prolia (denosumab) as a treatment to increase bone mass in men with osteoporosis at high risk for fracture, the company announced. "While osteoporosis and osteoporosis-related fractures are more commonly associated with post-menopausal women, osteoporosis in men is a significant issue that is increasing in prevalence," commented Sean E. Harper, Amgen's executive vice president of R&D.

The drugmaker noted that the new indication for the RANK ligand inhibitor is based on data from the ADAMO trial, which included 242 men between the ages of 30 and 85 years with low bone mineral density (BMD). Results from the study showed that treatment with Prolia resulted in significantly greater gains in BMD at the lumbar spine compared to placebo. In addition, data indicated that men in the trial who received Prolia experienced BMD increases at all other skeletal sites assessed compared to placebo, including at the total hip and at the femoral neck.

Prolia, which is administered subcutaneously every six months, was approved by the FDA in 2010 to treat post-menopausal women at increased risk of fractures. The drug is also authorised to increase bone mass in women with breast cancer and in certain men with non-metastatic prostate cancer. Sales of Prolia in the second quarter reached $120 million, up 36 percent on a sequential basis.

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