UCB and Amgen file for romosozumab approval in USA

Belgium’s UCB (Euronext Brussels: UCB) and biotech major Amgen (Nasdaq: AMGN) have submitted a Biologics License Application (BLA) to the US Food and Drug Administration 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.

“Osteoporosis is a chronic disease, largely asymptomatic, and often undetected until a fragility fracture occurs. Many patients 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 at UCB, adding: “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.”