Amgen (NASDAQ: AMGN) today announced the U.S. Food and Drug Administration (FDA) 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.
"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, M.D., executive vice president of Research and Development at Amgen. "Fractures can be a life-changing event, so we are pleased that we can offer a new treatment option for the growing number of men with osteoporosis at high risk for fracture."
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 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), the pivotal Phase 3 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.
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.