UCB and Amgen Announce FDA Advisory Committee Meeting to review EVENITY™ (Romosozumab) for the Treatment of Osteoporosis in Postmenopausal Women at High Risk for Fracture
BRUSSELS, Belgium, and THOUSAND OAKS, Calif. (Nov. 30, 2018) – Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) will review data supporting the Biologics License Application (BLA) for EVENITYTM (romosozumab) for the treatment of osteoporosis in postmenopausal women at high risk for fracture at a meeting on Jan. 16, 2019.
“We are currently seeing a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated 77 percent of women aged 67 or older remaining undiagnosed and untreated in the first 6 months after a fracture.1 This is a stark reminder of the need to improve post-fracture care and reduce the risk of future fractures,” said Dr. Pascale Richetta, head of bone and executive vice president, UCB. “We believe romosozumab has the potential to help postmenopausal women with osteoporosis who are at high risk for fracture, and we look forward to the interactions with the members of the Committee."
The romosozumab development program includes three pivotal Phase 3 studies that included more than 11,000 patients: FRAME,2 including 7,180 postmenopausal women with osteoporosis; and ARCH,3 including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and BRIDGE,4 including 245 men with osteoporosis. The BRUDAC committee will focus its discussion on the FRAME and ARCH studies in its review of the clinical benefit:risk profile of romosozumab, including the cardiovascular safety findings seen in the ARCH study, for the potential to reduce the risk of fractures and increase bone mineral density (BMD) in postmenopausal women with osteoporosis.
“After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year, and these fractures can be life-changing. Yet these patients often remain undiagnosed and untreated and could benefit from a potential new bone forming therapy that has been shown to reduce their risk of fracture within the first year,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We look forward to discussing the efficacy and safety data from our romosozumab clinical program with the members of the Committee.”
In July 2018, Amgen and UCB resubmitted the BLA to the FDA for romosozumab. Marketing authorization applications for romosozumab are also ongoing in other parts of the world including Europe and Japan.
- Cosman F, de Beur SJ, LeBoff MS, et al. Clinician’s Guide to Prevention and Treatment of Osteoporosis. Osteoporosis Int. 2014; 25(10): 2359–2381.
- Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME). Available at: https://clinicaltrials.gov/ct2/show/NCT01575834?term=NCT01575834&rank=1. Accessed November 2018.
- Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis. Available at: https://clinicaltrials.gov/ct2/show/NCT01631214?term=NCT01631214&rank=1. Accessed November 2018.
- A Double-blind Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis (BRIDGE). Available at: https://clinicaltrials.gov/ct2/show/NCT02186171?term=NCT02186171&rank=1. Accessed November 2018, 2018
About EVENITY™ (romosozumab)
Romosozumab is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the activity of sclerostin, which enables romosozumab to increase bone formation and reduce bone resorption. Romosozumab has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program included two large fracture trials comparing romosozumab to either placebo or active comparator in more than 11,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab.
About the Amgen and UCB Collaboration
Since 2004, Amgen and UCB have been working together under a collaboration and license agreement to research, develop and market antibody products targeting the protein sclerostin. As part of this agreement, the two companies continue to collaborate on the development of romosozumab for the treatment of osteoporosis. This gene-to-drug project demonstrates how Amgen and UCB are joining forces to translate a genetic discovery into a new medicine, turning conceptual science into a reality.
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