Amgen Inc. (AMGN: Quote) announced the U.S. Food and Drug Administration or FDA approved a new indication for Prolia or 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.
"While osteoporosis and osteoporosis-related fractures are more commonly associated with postmenopausal women, osteoporosis in men is a significant issue that is increasing in prevalence as life expectancies rise," said Sean Harper, executive vice president of Research and Development at Amgen.
The company said thatthe new indication for Prolia is based on results from the ADAMO trial3 (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), the pivotal Phase 3 study involving 242 men with low bone mineral density or 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.
The most common adverse reactions reported (per patient incidence > 5 percent) 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 percent.
Prolia was approved in the U.S. for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.
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by RTT Staff Writer
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