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FDA Approves New Indication for Prolia (Denosumab) for Treatment of Bone Loss in Men With Osteoporosis

RANK ligand inhibitor targets bone-destroying osteoclasts (Sept. 20)

Amgen announced on September 20 that 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 healthcare professional every 6 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 pivotal phase III ADAMO (A multicenter, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of DenosumAb 60 mg every six months versus placebo in Males with Osteoporosis) trial, which involved 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 with placebo (5.7% vs. 0.9%, respectively). The effects of Prolia on BMD were independent of age, baseline testosterone levels, BMD status, and estimated fracture risk.

Additional results showed that patients who received treatment with Prolia experienced BMD increases at all other assessed skeletal sites compared with placebo, including at the total hip (2.4% vs. 0.3%, respectively) and at the femoral neck (2.1% vs. 0.0%, respectively). Safety findings were consistent with what has been observed in studies of Prolia in postmenopausal women with osteoporosis. The most common adverse reactions were back pain, arthralgia, and nasopharyngitis.

Osteoporosis in men has recently been recognized as an important public health issue, as male life expectancies rise and the number of men over the age of 70 grows. Between 2010 and 2020, the number of men with osteoporosis is expected to increase by 17%. Approximately one in four men in the U.S. over the age of 50 years will experience an osteoporosis-related fracture in his remaining lifetime.

Prolia is the first approved therapy that specifically targets RANK ligand, an essential regulator of osteoclasts (the cells that break down bone). The drug is administered as a single 60-mg subcutaneous injection once every 6 months.

Prolia is currently approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk for fracture or for patients who have failed or are intolerant of other available osteoporosis therapies.

For more information, visit the Amgen Web site.

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