FDA Approves Romosozumab for Osteoporosis

By Kristin J. Kelley

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM

Romosozumab (marketed as Evenity) has been approved for postmenopausal women with osteoporosis and high fracture risk, and for those who don't tolerate other therapies. The FDA notes that due to serious cardiovascular adverse events seen in one of the drug's trials — including increased risk for cardiovascular death — it cannot be used in patients who've had a myocardial infarction or stroke in the previous year.

The monoclonal antibody works by increasing new bone formation.

In two trials, treatment with romosozumab lowered vertebral fracture risk (by 73% when compared with placebo and denosumab, and by 50% compared with alendronate).

Romosozumab was approved with a boxed warning for its cardiovascular risks. Clinicians should determine if the benefits outweigh the risks in their patients with heart disease risk factors. The most common side effects include headache, joint pain, and injection-site reactions.