The BLA for romosozumab is based on data from the pivotal Phase 3 placebo-controlled FRActure study in post-menopausal woMen with ostEoporosis (FRAME) in approximately 7,200 patients. UCB and Amgen plan to present results from the FRAME clinical trial at an upcoming medical congress.
“Osteoporosis is a large public health problem yet is often overlooked, even in patients who have already experienced an osteoporotic fracture,”1,5said Sean E. Harper, M.D., 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.”
Osteoporosis-related fragility fractures are common.,1,6 In the United States, one in two women over the age of 50 will experience an osteoporotic fracture.7 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.1
- Reginster JY, Burlet N. Osteoporosis: A still increasing prevalence. Bone. 2006 Feb;38 (2 Suppl 1):S4-9.
- 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/whosrisk. Accessed July 15, 2016.
- National Osteoporosis Foundation. What Women Need To Know. Available at: www.nof.org/prevention/general-facts/what-women-need-to-know. Accessed July 15, 2016.
- Wilk A et al. Post-fracture pharmacotherapy for women with osteoporotic fracture: analysis of a managed care population in the USA. Osteoporosis Int. 2014;25(12):2777-2786.
- American Academy of Orthopaedic Surgeons. Position Statement: Osteoporosis/Bone Health in Adults as a National Public Health Priority. December 2014. Available at: www.aaos.org/about/papers/position/1113.asp Accessed July 14, 2016.
- National Osteoporosis Foundation. What Is Osteoporosis and What Causes It? Available at: https://www.nof.org/patients/what-is-osteoporosis. Accessed July 15, 2016.