THOUSAND OAKS, Calif. and BRUSSELS, Nov. 30, 2018 /PRNewswire/ -- 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.
"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 EVENITY clinical program with the members of the Committee."
The EVENITY development program includes three pivotal Phase 3 studies that included more than 11,000 patients: FRAME,1 including 7,180 postmenopausal women with osteoporosis; ARCH,2 including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and BRIDGE,3 including 245 men with osteoporosis. The BRUDAC will focus its discussion on the FRAME and ARCH studies in its review of the clinical benefit:risk profile of EVENITY, 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.
"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 six months after a fracture.4 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 EVENITY 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."
In July 2018, Amgen and UCB resubmitted the BLA to the FDA for EVENITY. Marketing authorization applications for EVENITY are also ongoing in other parts of the world including Europe and Japan.
About EVENITY™* (romosozumab)
EVENITY 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 EVENITY to rapidly increase bone formation and reduce bone resorption simultaneously. EVENITY 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 EVENITY to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.
About the Pivotal EVENITY Clinical Trials
FRAME (Fracture study in postmenopausal women with osteoporosis) is a randomized, double-blind, placebo-controlled study that evaluated 7,180 postmenopausal women with osteoporosis. The study evaluated the effectiveness of EVENITY treatment (210 mg), compared with placebo, in reducing the risk of new vertebral fractures through 12 months. The study also evaluated the effectiveness of treating with EVENITY for 12 months followed by denosumab for 12 months, compared with placebo followed by denosumab, in reducing the risk of new vertebral fractures through 24 months.
ARCH (Active-controlled fracture study in postmenopausal women with osteoporosis at High risk of fracture) is a randomized, double-blind, alendronate-controlled study of EVENITY in 4,093 postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history. The study evaluated 12 months of EVENITY treatment (210 mg) followed by at least 12 months of alendronate treatment (70 mg), compared with alendronate treatment alone, to determine effectiveness in reducing the incidence of clinical fracture (non-vertebral fracture and clinical vertebral fracture) and new vertebral fracture.
BRIDGE (Placebo-controlled study evaluating the efficacy and safety of romosozumab in treating men with osteoporosis) is a randomized, double-blind, placebo-controlled study of 245 men aged 55-90 years with osteoporosis and a history of fragility fracture (excluding hip fracture) or vertebral fracture. The study evaluated the effectiveness of EVENITY treatment for 12 months, compared with placebo, in increasing bone mineral density (BMD) at the lumbar spine and the effect on BMD at the femoral neck and total hip.
About Fragility Fractures
Worldwide, one in three women and one in five men, over the age of 50, will suffer a fragility fracture due to osteoporosis and with an aging population these numbers will rise.2 Yet despite this, we are currently seeing a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated four out of five patients remaining undiagnosed and untreated after a fracture.1 Without proper care or access to effective intervention options, they remain at risk of painful and disabling fractures in the future.
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.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 7,700 people in approximately 40 countries, the company generated revenue of € 4.2 billion in 2016. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news
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*The trade name EVENITY™ is provisionally approved for use by the U.S. Food and Drug Administration and the European Medicines Agency.
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- 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 27, 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 27, 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 27, 2018.
- Cosman F, de Beur SJ, LeBoff MS, et al. Clinician's Guide to Prevention and Treatment of Osteoporosis. Osteoporos Int. 2014; 25(10): 2359–2381.
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