Amgen Submits Biologics License Application for FDA Approval of Denosumab in Women With Postmenopausal Osteoporosis and in Patie
THOUSAND OAKS, Calif., Dec. 19 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN), today announced submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for denosumab, an investigational RANK Ligand inhibitor. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA submission contains data from six Phase 3 trials involving more than 11,000 patients.
"Two Phase 3 pivotal studies with fracture endpoints, in the PMO and prostate cancer settings, demonstrated denosumab's ability to reduce fracture, and all six studies showed denosumab's ability to increase bone mineral density at all skeletal sites measured," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Today's submission marks a significant step toward realizing our goal of making this important therapeutic available to patients at risk for fractures, for whom there is a significant need for new therapies."
Amgen also intends to submit a marketing application shortly in the European Union, Switzerland, Canada and Australia for use of denosumab in these indications.
Postmenopausal osteoporosis affects more than 200 million people worldwide(1), and can have devastating consequences. In the United States (U.S.), one in two women over the age of 50 will fracture in her lifetime(2), and one third of those who fracture will break another bone within one year.(3) Osteoporotic fractures cost the U.S. healthcare system more than $20 billion annually(2), equivalent to the cost associated with cardiovascular disease and asthma.(2,4,5) It has been reported that osteoporosis results in more hospital bed-days than stroke, myocardial infarction or breast cancer.(6)
In the U.S., prostate cancer is the most common cancer in men and breast cancer is the most common cancer in women.(7) It is common for prostate cancer and breast cancer patients to receive hormone ablation therapies that can lead to a decrease in bone mass and increased risk of fractures. Currently there are no approved therapies for bone loss in patients undergoing hormone ablation for either prostate or breast cancer.
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). Denosumab is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. Denosumab is being studied in a range of bone loss conditions including PMO, rheumatoid arthritis, and bone loss in patients undergoing hormone ablation for prostate and breast cancer, as well as for its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
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(2) "Osteoporosis Fast Facts." Washington (DC): National Osteoporosis Foundation. Accessed at http://www.nof.org/osteoporosis/stats.html.
(3) Foley K, et al, 2008.
(4) Burge R, et al. J Bone Miner Res. 2007; 22:465-475
(5) "Economic Cost of Cardiovascular Diseases." Dallas (TX): American Heart Association. Accessed at http://www.americanheart.org/statistics/10econom.html.
(6) Lippuner K, et al. "Incidence and direct medical costs of hospitalisations due to osteoporotic fractures in Switzerland." Osteoporosis International. 1997;7:414-25.
(7) American Cancer Society(R). Available at: http://www.cancer.org. Accessed October 20, 2008.
SOURCE Amgen Inc.