FDA Panel Recommends Approval of Romosozumab for Osteoporosis

By Kelly Young

Edited by André Sofair, MD, MPH, and William E. Chavey, MD, MS

An advisory panel to the FDA has recommended that the agency approve romosozumab (Evenity) for postmenopausal women with osteoporosis and high fracture risk. The committee voted 18 to 1 in favor of approval.

Romosozumab is a monoclonal antibody that stimulates bone formation by binding to sclerostin. The 210-mg dose is administered subcutaneously monthly with treatment duration limited to 1 year.

In one trial, romosozumab was associated with an absolute risk reduction of vertebral fractures of 1.3% relative to placebo at 12 months. Osteonecrosis of the jaw and atypical femoral fractures were rare in clinical trials, according to briefing materials supplied to the FDA panel.