A federal health panel on Thursday said a highly anticipated bone drug from Amgen benefits patients with osteoporosis, but should not be used to prevent the disease because of long-term safety questions.
U.S. Food and Drug Administration experts unanimously voted that Amgen's injectable drug denosumab helps prevent bone fractures in women with postmenopausal osteoporosis. But panelists said the drug should only be used by patients who face the greatest risk of fractures.
In a separate 12-3 vote, the panel ruled against using the drug as a preventive measure for women with low bone density. The FDA is not required to follow the group's advice, though if usually does. The mixed endorsement puts denosumab's multibillion-dollar sales potential in question, even as Wall Street has pegged the Thousand Oaks company's future growth to the medication.
Amgen also wants the FDA to approve the drug, whose proposed brand name is Prolia, as a treatment for osteoporosis in patients being treated for breast and prostate cancer.
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