UCB and Amgen submit FDA application for Osteoporosis drug

UCB and Amgen today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for romosozumab, an investigational, monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Romosozumab works by binding and inhibiting sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption.

“We are pleased to submit the first regulatory submission for romosozumab, and are committed to seeking global regulatory approvals in the hopes of making this important therapy available for appropriate patients at increased risk of fracture.”

The BLA for romosozumab is based on data from the pivotal Phase 3 placebo-controlled fracture study in post-menopausal women with osteoporosis, approximately 7,200 patients. UCB and Amgen plan to present results from the clinical trial at an upcoming medical congress.

Osteoporosis-related fragility fractures are common. In the United States, one in two women over the age of 50 will experience an osteoporotic fracture yet data shows that only about 20 percent of women who have experienced a fracture receive any type of osteoporosis treatment during the first year post fracture.