FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Approves Amgen’s Evenity for Postmenopausal Women

April 18, 2019

Amgen finally snagged FDA approval for its osteoporosis treatment Evenity (romosozumab-aqqg), a medication intended for postmenopausal women at high risk of bone fractures.

The humanized monoclonal antibody is the first treatment of its kind to both increase bone formation and decrease bone resorption.

Evenity was previously shot down by the agency in 2017. The approved medication requires a boxed warning telling patients that it may increase the risk of heart attack, stroke and cardiovascular death.

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