"There remains a need for additional alternatives to treat postmenopausal osteoporosis, and there are no currently approved treatments for bone loss due to hormone ablation therapy," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. "Based on efficacy and safety data from 30 studies involving 12,000 patients, Amgen believes that denosumab would offer a meaningful treatment option for patients with these conditions."
Amgen will discuss the efficacy, safety and overall benefit:risk profile of denosumab, and will propose an approach to post-marketing surveillance and risk management should the FDA decide to approve denosumab for commercial use.
The ACRHD will discuss the use of denosumab in each of four indications outlined in the BLAs:
-- Treatment of osteoporosis in postmenopausal women
-- Prevention of osteoporosis in postmenopausal women
-- Treatment and prevention of bone loss associated with hormone ablation in patients with breast cancer
-- Treatment and prevention of bone loss associated with hormone ablation in patients with prostate cancer
"Denosumab has a positive benefit:risk profile in these patient populations, and we look forward to discussing our data with the ACRHD today," Perlmutter said. "We also look forward to discussing our proposed programs to monitor long-term safety with denosumab."
Amgen and FDA briefing materials are available online at www.fda.gov and www.amgen.com.
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 postmenopausal osteoporosis and bone loss in patients undergoing hormone ablation for prostate and breast cancer.
Often referred to as the "silent epidemic," osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. In the U.S. today, nearly eight million women suffer from osteoporosis.(i) The World Health Organization (WHO) has recently identified osteoporosis as a priority health issue along with other major non-communicable diseases.
The economic burden of osteoporosis is comparable to that of other major chronic diseases; for example, in the U.S., the costs associated with osteoporosis-related fractures are equivalent to those of cardiovascular disease and asthma.(ii)(iii)(iv) It has been reported that osteoporosis results in more hospital bed-days than stroke, myocardial infarction or breast cancer.(v)
Bone Loss Due to Hormone Ablation
In the U.S., prostate cancer is the most common cancer in men and breast cancer is the most common cancer in women. 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.
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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(i) http://www.nof.org/osteoporosis/diseasefacts.htm, accessed, 3/18/2009: Main bullet #5
(ii) Burge R, et al. J Bone Miner Res. 2007; 22:465-475
(iii) "Osteoporosis Fast Facts." Washington (DC): National Osteoporosis Foundation. Accessed on February 24, 2009 at http://www.nof.org/osteoporosis/stats.html.
(iv) "Economic Cost of Cardiovascular Diseases." Dallas (TX): American Heart Association. Accessed on February 24, 2009 at http://www.americanheart.org/statistics/10econom.html
(v) Lippuner K, et al. "Incidence and direct medical costs of hospitalisations due to osteoporotic fractures in switzerland." Osteoporosis International.1997;7:414-25.
CONTACT: Amgen, Thousand Oaks
Sarah Reines: (805) 447-9783 (media, osteoporosis)
Lisa Rooney: (805) 447-6437(media, oncology)
Arvind Sood: (805) 447-1060 (investors)
SOURCE Amgen Inc.