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11-04-2019 | Osteoporosis | News

approvalsWatch

FDA approves romosozumab for fracture prevention in osteoporosis

medwireNews: The monoclonal antibody romosozumab has been approved in the USA for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

These patients include women with a history of or multiple risk factors for fracture, and those with an inadequate response or intolerance to other treatments for osteoporosis, says the FDA.

The approval is based on the results of two clinical trials, one of which showed that romosozumab significantly reduced the risk for vertebral fracture compared with placebo. The other trial demonstrated a significantly lower risk with romosozumab versus alendronate, but at the cost of an elevated risk for heart attack, stroke, and cardiovascular death.

Editor's recommendation

12-10-2017 | Osteoporosis | News

Romosozumab shows promise for fracture prevention in women with osteoporosis

Results of the phase III ARCH trial suggest that women with osteoporosis who are treated with romosozumab are less likely to experience fractures, but may have an increased risk for cardiovascular events, compared with those given alendronate.

Therefore, the FDA cautions that romosozumab “contains a boxed warning on its labeling stating that it may increase the risk of heart attack, stroke and cardiovascular death and should not be used in patients who have had a heart attack or stroke within the previous year.”

By Claire Barnard

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group

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