Amgen and UCB submit BLA for romosozumab to the FDA

Based on Phase III FRAME Study in postmenopausal women with osteoporosis.

"Osteoporosis is a large public health problem yet is often overlooked, even in patients who have already experienced an osteoporotic fracture," said Sean E. Harper, executive vice president of Research and Development at Amgen. "This BLA submission is an exciting milestone; romosozumab has the potential to reduce the risk of fractures and help patients suffering from this serious disease."

The BLA for romosozumab is based on data from the pivotal Phase III placebo-controlled FRActure study in postemenopausal woMen with ostEoporosis (FRAME) in approximately 7,200 patients. Amgen and UCB plan to present results from the FRAME clinical trial at an upcoming medical congress.

"Osteoporosis is a chronic disease, largely asymptomatic, and often undetected until a fragility fracture occurs. Many patients often view fragility fractures as part of aging, but these fractures are an indication of a weakened skeleton and a signal for intervention with medication," said Dr Pascale Richetta, head of bone and executive vice president, UCB. "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."