FDA Approves Evenity for Osteoporosis

April 9, 2019

Evenity (romosozumab-aqqg) has been approved to treat postmenopausal women at high risk of bone fractures.

The FDA has approved Evenity (romosozumab-aqqg, Amgen) as a treatment for osteoporosis in postmenopausal women who are at high risk for bone fractures. This includes women with a history of osteoporotic fracture, who have several risk factors for fracture, or who have failed on or are intolerant of other treatments for osteoporosis.

The drug is a monoclonal antibody that blocks the effects of the protein sclerostin and works mainly by increasing new bone formation. The dosage for Evenity is two injections, one after the other, once a month, administered by a healthcare professional. However, the bone-forming effects wane after 12 doses, and labeling states that no more than 12 doses should be used. If osteoporosis therapy is still needed after 12 doses, the patient should be started on an osteoporosis treatment that reduces bone breakdown.

More than 10 million people in the United States have osteoporosis, and it is most common in postmenopausal women. Evenity is a new option for older women with osteoporosis,” says Hylton V. Joffe, MD, director of the FDA’s Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products. “But Evenity may increase the risk of heart attack, stroke and cardiovascular death so 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.”

The labeling for Evenity contains a boxed warning stating that 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. Healthcare professionals should also consider whether the benefits of Evenity outweigh its risks in those with other risk factors for heart disease, and should discontinue it in any patient who experiences a heart attack or stroke during treatment. Common side effects included joint pain and headache. Injection site reactions were also observed.

The safety and efficacy of Evenity were demonstrated in two clinical trials that enrolled more than 11,000 women with postmenopausal osteoporosis. In the first trial, one year of treatment with Evenity lowered the risk of a new vertebral fracture by 73% compared to placebo. This benefit was maintained over the second year of the trial when Evenity was followed by one year of denosumab compared to placebo followed by denosumab. In the second trial, one year of treatment with Evenity followed by one year of alendronate reduced the risk of a new vertebral fracture by 50% compared to two years of alendronate alone. Evenity followed by alendronate also reduced the risk of fractures in other bones compared to alendronate alone. Evenity increased the risk of cardiovascular death, heart attack and stroke in the alendronate trial, but not in the placebo trial.