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|FDA Classifies Prolia(TM) (Denosumab) Complete Response Submission and Targets Action Date|
THOUSAND OAKS, Calif., Feb 19, 2010 /PRNewswire via COMTEX/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company's Complete Response submission for Prolia(TM) (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010.
In October 2009, the FDA's Division of Reproductive and Urologic Products issued a Complete Response Letter for the Biologic License Application (BLA) for Prolia in the treatment and prevention of postmenopausal osteoporosis. The letter requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program. The letter did not require additional pre-marketing clinical trials to complete the review of the treatment indication. The FDA also requested all updated safety data related to Prolia. Amgen submitted the requested information for the treatment indication in late January 2010.
Amgen continues to work with the FDA to determine appropriate next steps regarding its indications for Prolia in the prevention of postmenopausal osteoporosis, as well as in the treatment and prevention of bone loss due to hormone ablation in breast and prostate cancer patients.
Denosumab is the first and only therapy in late stage development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone). It is under study for administration every six months as a subcutaneous injection just under the skin and is being investigated for its potential to inhibit all stages of osteoclast development through a targeted mechanism. Denosumab is also being studied in a range of other bone loss conditions including rheumatoid arthritis, and for its potential to delay bone metastases and inhibit and treat bone destruction in patients with advanced 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)
Along with proper diet and weight-bearing exercise, medications can help slow bone loss and reduce the risk of fracture. Yet despite the availability of osteoporosis treatments for more than 10 years, the worldwide lifetime risk of fracture remains high at 30-50 percent for women and 15-30 percent for men.(vi) It is estimated that fewer than 50 percent of patients adhere to their current therapy for more than one year(vii)(viii)(ix), which may leave many patients insufficiently protected against bone loss.
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 http://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 Feb. 19, 2010 and expressly disclaims any duty to update information contained in this news release.
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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
vi. International Osteoporosis Foundation (2002). Osteoporosis in the Workplace: The social, economic and human costs of osteoporosis on employees, employers and governments
vii. Rossini M et al. Osteoporosis Int. 2006;17:914-921
viii. Payer J et al. Biomed Pharmacother 2007;61:191-193
ix. McCombs JS et al. Maturitas 2004;48:271-287