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Amgen’s Denosumab Gets Priority Review

The U.S. Food and Drug Administration granted priority review designation to Amgen’s new drug denosumab for the treatment of bone problems in cancer patients. The company filed for FDA approval of denosumab for the treatment of bone metastases in mid-May. With the priority-review designation, Amgen can expect a decision from the FDA as soon as Nov. 18. Denosumab, with the name of Prolia, was approved by the FDA as an osteoporosis treatment for postmenopausal women who face a high risk of bone fractures June 1. The drug is widely considered key to Amgen’s future growth, especially in the area of oncology. The FDA’s approval could boost sales of the new drug to roughly $3 billion by 2015, according to analysts.

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