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You are here: Home / Articles / FDA Approves New Osteoporosis Medication

FDA Approves New Osteoporosis Medication

April 23, 2019 • By Michele B. Kaufman, PharmD, BCGP

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In early April, the U.S. Food and Drug Administration (FDA) approved romosozumab-aqqg (Evenity) for treating postmenopausal women with osteoporosis at high risk of fracture.1 These high-risk patients include those who have a history of osteoporotic fracture, multiple risk factors for fracture or are intolerant to other osteoporosis therapies.

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Romosozumab-aqqg is a monoclonal antibody that blocks the effects of the sclerostin protein. It builds bone by increasing bone formation and—to a lesser extent—reducing bone resorption. One dose comprises two injections given subsequently, once monthly, by a healthcare professional. After 12 doses, the treatment’s bone forming effect wanes, so no more than 12 doses should be given. After romosozumab-aqqg therapy is complete, continuing treatment with an anti-resorptive agent should be considered.

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Background
This FDA approval is based on the results of two phase 3 clinical trials. In the placebo-controlled FRAME trial, romosozumab-aqqg treatment led to significant reductions of new vertebral fractures at Month 12 compared with placebo. Romosozumab-aqqg-treated patients had significant reductions in fracture risk through Year 2, after receiving romosozumab-aqqg for Year 1. In Year 2, all patients transitioned to denosumab.

Additionally, romosozumab-aqqg-treated patients significantly increased bone mineral density of the lumbar spine, hip and femoral neck compared with placebo-treated patients at Month 12. For romosozumab-aqqg-treated patients who transitioned to denosumab, bone mineral density continued to increase through Month 24. The most common adverse reactions reported in clinical trials were arthralgia and headache.

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On the label, romosozumab-aqqg has a boxed warning, advising that it may increase the risk of having myocardial infarction, stroke and/or cause cardiovascular death. Romosozumab-aqqg should not be initiated in patients who have experienced myocardial infarction or stroke within the prior year.


Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

Reference

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  1. Amgen Inc. News release: FDA Approves Evenity (romosozumab-aqqg) for the treatment of osteoporosis in postmenopausal women at high risk for fracture. 2019 Apr 9.

Filed Under: Drug Updates Tagged With: FDA, Osteoporosis, postmenopausal, postmenopausal women, romosozumab-aqqg, U.S. Food and Drug Administration (FDA)

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