FDA Approves Bone-Building Osteoporosis Treatment Geared Toward High-Risk Women

The U.S. Food and Drug Administration (FDA) has approved a drug treatment engineered for postmenopausal women with a high risk of bone fractures, reports Philly Voice . Evenity, or romosozumab, increases a person's ability to form new bones, which the FDA noted is essential for those suffering from bone-deteriorating diseases. Doses are administered in two monthly back-to-back injections, with the FDA classifying "high risk" women as those with a history of fractures, or who have multiple risk factors that could lead to fracture, or who have unsuccessfully tried other osteoporosis treatments. Evenity's safety and efficacy was verified in two clinical trials enlisting more than 11,000 subjects with postmenopausal osteoporosis. Evenity's effectiveness stops after 12 doses, so users should not exceed that number, the FDA advises. The agency recommends those requiring further treatment at that point should start therapy for bone breakdown. "Evenity may increase the risk of heart attack, stroke, and cardiovascular death so it's important to carefully select users for this therapy, which includes avoiding use in those who have had a heart attack or stroke within the previous year," cautioned Hylton Joffe with the Center for Drug Evaluation and Research's Division of Bone, Reproductive, and Urologic Products.