THOUSAND OAKS, Calif. and BRUSSELS, July 12, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) today announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY™* (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY increases bone formation and reduces bone resorption simultaneously to increase bone mineral density (BMD) and reduce the risk of fracture.
"A fracture due to osteoporosis can be a life-altering event, and EVENITY has the potential to reduce fracture risk in patients at high risk due to a prior fracture," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to continuing our work with the FDA to demonstrate the benefit:risk profile for EVENITY. Our hope is to bring to patients an innovative treatment option that addresses a serious unmet medical need."
The BLA for EVENITY now adds results from two more recent pivotal Phase 3 trials: the ARCH study, an alendronate-active comparator trial including 4,093 postmenopausal women with osteoporosis who experienced a fracture, and the BRIDGE study, including 245 men with osteoporosis. The FDA will evaluate the clinical benefit:risk profile of EVENITY, including the cardiovascular safety signal seen in the ARCH study, for the potential to reduce the risk of fractures and increase BMD in postmenopausal women with osteoporosis. The original FDA submission included data from a comprehensive Phase 1 and Phase 2 program and the Phase 3 placebo-controlled FRAME study, including 7,180 postmenopausal women with osteoporosis.
"The burden of osteoporosis can have tremendous impact on a patient's life," said Pascale Richetta, M.D., head of bone and executive vice president at UCB. "We are one step closer in our ability to bring this first of its kind treatment to thousands of women affected by fragility fractures each year."
In the U.S., one in two women over the age of 50 will suffer a fragility (or osteoporotic) fracture due to osteoporosis, and with an aging population these numbers will likely rise.1 Yet despite this, there is currently 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.2 Without proper care or access to effective intervention options, they remain at risk of painful and disabling fractures in the future.
The European Medicines Agency (EMA) and the Pharmaceuticals and Medical Device Agency (PMDA) in Japan are currently reviewing marketing applications for EVENITY and interactions with the agencies are ongoing.
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 11,000 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 BMD at the lumbar spine and the effect on BMD at the femoral neck and total hip.
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 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 one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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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1 National Osteoporosis Foundation. What is Osteoporosis and What Causes It? https://nof.org/patients/what-is-osteoporosis. Accessed June 28, 2018.
2 Nguyen TV, Center JR, Eisman JA (2004) Osteoporosis: underrated, underdiagnosed and undertreated. Med J Aust. 180:S18.