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THOUSAND OAKS, Calif. — The Food and Drug Administration has approved a new usage for an Amgen drug, the drug maker said.
The biotech manufacturer announced the FDA approval of Prolia (denosumab) to increase bone mass in men with osteoporosis who are at high risk for fracture. The drug already was approved for osteoporosis in postmenopausal women.
According to the National Institutes of Health, the number of men with osteoporosis is expected to increase as the number of men older than 70 years grows, and about one-quarter of men older than 50 years will have an osteoporosis-related fracture in their lifetime, according to the National Osteoporosis Foundation, which estimated the condition affects 2 million men, with 12 million more at risk.