Amgen files denosumab for FDA approval

Amgen announced that it filed denosumab for approval to the FDA to treat and prevent postmenopausal osteoporosis in women, as well as to treat bone loss in patients undergoing hormone ablation for either prostate or breast cancer.

The filing contains data from six late-stage studies involving more than 11 000 patients, Amgen stated, adding that it soon plans to submit the compound to EU regulators for use in the same indications. In September, the company released updated trial results which showed that the drug reduced the risk of vertebral fractures in postmenopausal women with osteoporosis by 68 percent, compared with placebo.

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