FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture

FDA approved on Tuesday romosozumab-aqqg (Evenity—Amgen) for the treatment of osteoporosis in postmenopausal women at high risk of fracture. These women have a history of osteoporotic fracture or multiple risk factors for fracture, or they have failed or are intolerant of other osteoporosis treatments.

FDA approved on Tuesday romosozumab-aqqg (Evenity—Amgen) for the treatment of osteoporosis in postmenopausal women at high risk of fracture. These women have a history of osteoporotic fracture or multiple risk factors for fracture, or they have failed or are intolerant of other osteoporosis treatments. One dose of romosozumab-aqqg—a monoclonal antibody that blocks the effects of the sclerostin protein—consists of two injections, one after the other, administered once a month by a health care professional. Because the bone-forming effect of the drug wanes after 12 doses, FDA notes that more than 12 doses should not be used. Women who need additional treatment should begin an osteoporosis treatment that reduces bone breakdown. In the clinical trials used to demonstrate the safety and efficacy of romosozumab-aqqg, the drug increased the risk of cardiovascular death, heart attack, and stroke in the trial using alendronate, another osteoporosis therapy, but not in the placebo trial. Romosozumab-aqqg includes a boxed warning that states 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. Common adverse effects associated with the drug included joint pain and headache.