UCB (Euronext Brussels: UCB) and Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) 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 the activity of the protein sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption.
“Once a patient suffers a fragility fracture the burden of osteoporosis can have a tremendous impact on a patient’s life,”1,2 said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “We are pleased with the FDA’s acceptance of the BLA filing for review and hope to continue the regulatory process towards U.S. approval to introduce a potential new therapy to reduce the risk of fractures for this patient population.”
The BLA, submitted on July 19, 2016, is based on data from the pivotal Phase 3 placebo-controlled FRActure study in postemenopausal woMen with ostEoporosis (FRAME) in approximately 7,200 patients.
“We believe romosozumab could serve as an important therapeutic option for osteoporosis patients with an increased risk of fracture,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We look forward to potentially providing a new therapy to address a critical unmet medical need and further supporting patients worldwide.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2017 for romosozumab.
- International Osteoporosis Foundation. The Global Burden of Osteoporosis. What you need to know. Available at: http://www.iofbonehealth.org/data-publications/fact-sheets/what-you-need-know-about-osteoporosis. Accessed July 14, 2016.
- International Osteoporosis Foundation. Who’s at Risk? 2015. Available at: http://www.iofbonehealth.org/whos-risk. Accessed July 15, 2016.