UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) 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.
"Osteoporosis is a chronic disease, largely asymptomatic, and often undetected until a fragility fracture occurs.1,2,3 Many patients view fragility fractures as part of aging4 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.
