The FDA has approved romosozumab-aqqg (Evenity, Amgen) to treat osteoporosis in postmenopausal women at high risk of fracture. These include women with previous osteoporotic fracture or multiple risk factors for fracture, or who have failed or are intolerant to other osteoporosis therapies.
Romosozumab-aqqg is a monoclonal antibody that blocks the effects of sclerostin and increases new bone formation. As the bone-forming effect subsides after 12 doses, additional doses should not be used. If further osteoporosis therapy is required, patients should begin a treatment that reduces bone disintegration.
Romosozumab-aqqg’s safety and efficacy were demonstrated in two clinical trials involving more than 11,000 women with postmenopausal osteoporosis. In the first trial, one year of treatment with romosozumab-aqqg lowered the risk of new vertebral fractures by 73% compared to placebo.
In the second trial, one year of treatment with romosozumab-aqqg followed by one year of alendronate reduced the new vertebral fracture risk by 50% compared to two years of alendronate alone. Also, romosozumab-aqqg followed by alendronate reduced nonvertebral fracture risk compared to alendronate alone.
Romosozumab-aqqg increased the risk of cardiovascular death, heart attack, and stroke in the alendronate trial, but not in the placebo trial. The drug has a boxed warning about the potential increase in heart attack risk, stroke, and cardiovascular death, and should not be used in patients who have had a heart attack or stroke within the previous year.
Source: FDA, April 9, 2019