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WASHINGTON -- The FDA approved romosozumab (Evenity) for osteoporosis in postmenopausal women at high risk for fracture, the .

One dose of the bone anabolic agent, a monoclonal antibody targeting the protein sclerostin to support new bone formation, would be administered in two back-to-back injections each month. Due to a treatment plateau seen after a year of therapy in the drug's trials, no more than 12 doses are recommended.

This approval doesn't come as much of a surprise, after members of the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 18-1 in favor of the treatment's approval in January.

In the clinical program supporting the approval, which included more than 11,000 postmenopausal women, one year of romosozumab resulted in a 73% reduced risk for a new spine fracture compared with placebo. Romosozumab also showed a significant risk reduction for fracture when it followed denosumab (Xgeva, Prolia) or preceded alendronate (Fosamax, Binosto) treatment.

However, cardiovascular safety concerns with the drug were identified during the trials, mainly increased incidence of MI and stroke. Consequently, romosozumab will carry a boxed warning about potential increased risk for heart attack, stroke, and cardiovascular death -- a suggestion originally proposed by the manufacturer, Amgen.

Hylton Joffe, MD, MMSc, director of the Center for Drug Evaluation and Research's Division of Bone, Reproductive and Urologic Products, recommended to prescribers that "it's important to carefully select patients for this therapy, which includes avoiding use in patients who have had a heart attack or stroke within the previous year."

Prior to approval, Amgen (in partnership with UCB) also already agreed to a high-quality, post-approval observational study to monitor these heart risks.

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