New Osteoporosis Drug Under FDA Scrutiny

A new drug for treating osteoporosis is up for approval by the FDA. An advisory panel of experts has recommended that denosumab, a biotech compound made by Amgen, be approved for treating postmenopausal women with osteoporosis. These are the people who are at greatest risk for fractures. A new study shows that denosumab injected twice a year cut the rate of fractures of the vertebrae from about 7 percent to just over 2 percent, a relative risk reduction of 68 percent.
The panel did not recommend that the drug be used in treating cancer patients whose treatment has weakened their bones, although a study in The New England Journal of Medicine shows that denosumab increased bone mineral density and decreased spinal fractures in men being treated for prostate cancer. The advisory panel is concerned about an increased risk of infection and cancer among patients given denosumab. If the FDA approves the drug, it will become available under the brand name Prolia.
[New England Journal of Medicine, Aug. 20, 2009]