Amgen osteoporosis drug denosumab backed by FDA panel

Food and Drug Administration

The drug, denosumab, for treating osteoporosis in post menopausal women and men being treated for prostrate cancer, was unanimously backed by the advisory panel of Food and Drug Administration (FDA).

FDA is yet to decide whether the drug should be recommended for preventive treatment. This decision is scheduled to be made in October and although the FDA usually considers the panel's recommendations it is not obligated to do so. Amgen Inc., the biotech leader has hopes of marketing and selling the drug as Prolia.

The panel is still evaluating whether denosumab should be used in patients undergoing hormone therapy, to treat breast cancer or prostrate cancer, which increase the risk of fractures.

The recommendations of the panel, which met in Gaithersburg, Md., were a victory for the Thousand Oaks firm, said Amgen spokeswoman Kerry Beth Daly. "I think it's a very good day for osteoporosis patients."

Denosumab is mainly aimed at treating patients suffering from osteoporosis but Amgen will make much more money if it also gets approval from the FDA to market it as a preventive drug.

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