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Bone, Reproductive and Urologic Drugs Advisory Committee

The committee discussed a biologics license application (BLA) for Evenity (romosozumab) injection, submitted by Amgen, for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant of other available osteoporosis therapy.. A majority of the committee, 16of 19 members, voted that the overall benefit/risk profile of romosozumab is acceptable to support approval for the proposed osteoporosis use.