Amgen, Inc. : Amgen : FDA Approves Use of Prolia for Men With Osteoporosis
09/20/2012| 07:02pm US/Eastern
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By Kristin Jones
Amgen Inc. (AMGN) said the U.S. Food and Drug Administration has approved a new use for its bone-building drug Prolia, allowing it to be offered to men with osteoporosis.
The new indication is based on a study showing that a 60-milligram dose of denosumab every six months led to bone-mass increases for men with osteoporosis, compared with a placebo.
Prolia, which is administered as an injection, was previously approved only for postmenopausal women with the bone disease.
"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.
The company estimates that around one in four men in the U.S. over the age of 50 will have an osteoporosis-related fracture in his remaining lifetime.
Amgen reported in July that its second-quarter earnings rose 8.2% as weaker sales of the biopharmaceutical company's anemia drugs were offset by growth of other treatments.
Amgen has been seeking to bolster its research-and-development pipeline and grow sales of its bone-building drugs to help offset declining sales of its anti-anemia drugs, which have slumped in recent years due to safety concerns and intensifying competition.
Shares closed Thursday at $82.30 and were unchanged after hours. Through the close, the stock was up 28% so far this year.
-Write to Kristin Jones at kristin.jones@dowjones.com
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