Advisory Committee Questions

DISCUSSION: Discuss whether the cardiovascular safety of romosozumab has been adequately characterized. If additional safety data are needed, discuss the type(s) of data that are needed and whether these data should be obtained pre-approval or post-approval.

2. DISCUSSION: Amgen is seeking an indication for the treatment of osteoporosis in postmenopausal women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Discuss whether the benefit/risk profile of romosozumab could be improved by further narrowing the indicated population to patients at low cardiovascular risk, and if so, how to define the narrowed population.

3. VOTE: Is the overall benefit/risk profile of romosozumab acceptable to support approval?

A) Yes, for Amgen’s proposed indication (treatment of osteoporosis in postmenopausal women at high risk of fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy)

B) Yes, but for a different indication

C) No

Amgen's Evenity Faces CV Safety Gauntlet At US FDA Advisory Cmte.

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