U.S. Food and Drug Administration has approved new use for bone building drug Prolia, permitting physician to prescribe in men suffering from osteoporosis as said by Amgen Inc. (AMGN). Previously this drug was approved only in post-menopausal women suffering from bone abnormalities.
“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 E. Harper, executive vice president of research and development at Amgen.
It is estimated by National Osteoporosis Foundation, approximately 2 million Americans are suffering from osteoporoses and 12 million are at risk.
The new indication for Prolia is based on the findings o f ADAMO trial ( (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). Phase 3 study was conducted on 242 men with low bone density.
“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).”
“Additional results showed that patients in the study who received treatment with Prolia experienced BMD increases at all other skeletal sites assessed compared to placebo, including at the total hip (2.4 percent vs. 0.3 percent) and at the femoral neck (2.1 percent vs. 0.0 percent). Safety findings were consistent with what have been observed in other studies of Prolia in postmenopausal women with osteoporosis. The most common adverse reactions reported (per patient incidence > 5 percent) were back pain, arthralgia and nasopharyngitis. “
Source: Amgen Inc. (AMGN)
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