Results may set stage for regulatory approval
A new drug increases bone density and reduces the number of fractures in men fighting prostate cancer and in elderly women with bone loss, researchers report in two studies appearing August 11 in the New England Journal of Medicine.
The results of these clinical trials might clear the way for approval of the drug, called denosumab, by the Food and Drug Administration, which has scheduled an advisory panel to assess these and other data on August 13. “This certainly goes a long way toward fulfilling the criteria the FDA uses,” says Sundeep Khosla, an endocrinologist at the Mayo Clinic in Rochester, Minn., who didn’t participate in these trials.
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