Healthcare Industry News: kidney disease
News Release - May 19, 2008
Denosumab Osteoporosis Study Meets Primary and All Secondary Bone Mineral Density Endpoints in Alendronate (FOSAMAX(R)) Transition StudyPatients Transitioned from Alendronate to Denosumab Therapy Achieved Superior Gains in Bone Mineral Density Versus Those Continuing on Alendronate Therapy
THOUSAND OAKS, Calif.--(HSMN NewsFeed)--Amgen (NASDAQ: AMGN ) today announced findings from a head-to-head, double-blind trial comparing the effects of denosumab in post-menopausal women with low bone mass transitioned from weekly alendronate (FOSAMAX®) versus continued alendronate therapy on bone mineral density (BMD). The study demonstrated superior results for the primary and all secondary endpoints.
In this one-year, non-pivotal Phase 3 study, the group treated with twice-yearly subcutaneous injections of denosumab achieved significantly greater BMD gains at all sites measured including the total hip (primary endpoint), lumbar spine, femoral neck, distal radius, and hip trochanter compared with the group that continued on alendronate. For the primary endpoint, the relative magnitude of BMD improvement at the total hip was approximately 80 percent greater in the denosumab versus the alendronate group.
The incidence and types of adverse events observed in this study, including neoplasm and infection, were well-balanced between the denosumab and alendronate treatment groups. The most common adverse events across both treatment arms were back pain, arthralgia, and nasal pharyngitis.
“This is the second Phase 3 head-to-head study demonstrating that administration of denosumab resulted in superior BMD gains versus those achieved with alendronate,” said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. “Particularly important was the finding that in this population that had previously been treated with alendronate, patients transitioned to denosumab achieved greater BMD gains than those continuing on alendronate therapy.”
This was a randomized, double-blind, active controlled, parallel group study. Eligible patients had T-scores of ≤ -2.0 and ≥ -4.0 at the lumbar spine or total hip and had previously been treated with alendronate. A total of 504 women with low BMD participated in the study, with approximately 250 patients in each arm.
The study’s primary endpoint was to evaluate the effect of denosumab treatment (twice yearly 60 mg) on total hip BMD in women with low bone mass compared to that in patients continuing alendronate therapy (weekly 70 mg) at 12 months. The secondary endpoints included evaluation of the effects of transitioning to denosumab compared to continuing treatment with alendronate on percent change from baseline in BMD at the lumbar spine, hip trochanter, femoral neck, and distal radius.
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 post-menopausal osteoporosis, rheumatoid arthritis, and cancer treatment-induced bone loss (in breast cancer and prostate cancer patients), as well as for its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer.
Osteoporosis: Impact and Prevalence
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. The World Health Organization (WHO) has recently identified osteoporosis as a priority health issue along with other major non-communicable diseases.
Although fractures to the vertebrae and hip are the most commonly discussed osteoporotic fractures, they do not account for the majority of fractures. In fact, fractures at skeletal sites such as the wrist, pelvis, humerus, clavicle, femur, and lower leg (tibia/fibula) make up an estimated 59 percent of all osteoporotic fractures in the United States (U.S.)i.
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 asthmaii,iii,iv. It has been reported that osteoporosis results in more hospital bed-days than stroke, myocardial infarction or breast cancerv.
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.
This news release contains forward-looking statements that are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen’s most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of May 19, 2008 and expressly disclaims any duty to update information contained in this news release.
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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the FDA for the products.
The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.
FOSAMAX is a registered trademark of Merck & Co., Inc.
i Johnell O, Kanis JA. Osteoporosis Int. 2006; 17:1726-1733.
ii Burge R, et al. J Bone Miner Res. 2007; 22:465-475
iii “Osteoporosis Fast Facts.” Washington (DC): National Osteoporosis Foundation. Accessed at http://www.nof.org/osteoporosis/stats.html.
iv “Economic Cost of Cardiovascular Diseases.” Dallas (TX): American Heart Association. Accessed 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.
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