After reviewing safety and efficacy data from 30 clinical studies involving more than 12,000 patients, the Committee recommended approval of Prolia for the treatment of postmenopausal osteoporosis and for the treatment of bone loss in patients undergoing hormone ablation for prostate cancer. The Committee recommended against approval of Prolia to treat or prevent bone loss in women with breast cancer undergoing hormone ablation until additional data are available.
The Committee also recommended against approval of Prolia to prevent bone loss in low-risk patients in all three populations.
Finally, the panel recommended that Prolia have a Risk Evaluation and Mitigation Strategy (REMS), which could include a medication guide and a healthcare provider communications plan.
The FDA often seeks the advice of an advisory committee such as the ACRHD when evaluating a potential new treatment but is not required to follow its recommendation.
Postmenopausal osteoporosis is a major public health concern resulting in fractures that cause significant clinical morbidity, mortality, and healthcare burden, and there remains a need for additional treatment alternatives. Similarly, bone loss due to hormone ablation in the setting of cancer therapy results in significant morbidity, and has no currently approved treatments.
Patient safety is Amgen's top priority. Amgen proposed a comprehensive post-marketing surveillance program, including extensions of studies in the osteoporosis and oncology settings in which more than 5,000 patients will be treated with Prolia for up to 10 years, as well as ongoing studies in the advanced cancer setting. In addition, the Company proposed an observational study using healthcare databases that will involve approximately 380,000 women with postmenopausal osteoporosis for up to 5 years.
"Amgen looks forward to collaborating with the FDA to arrive at the best possible approach to make Prolia available to appropriate patients," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.
The FDA has targeted an Agency action within ten months of the application's submission date, resulting in a Prescription Drug User Fee Act (PDUFA) action date of Oct. 19, 2009.
About Prolia(TM) (denosumab)
Prolia 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). Prolia is being investigated for its potential to inhibit all stages of osteoclast activity through a targeted mechanism. Prolia 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.
In February 2009, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA), submitted by Amgen for Prolia for the treatment and prevention of osteoporosis in postmenopausal women and cancer treatment-induced bone loss in women and men receiving hormone therapy for either breast cancer or prostate cancer based on these studies and a parallel trial in women with breast cancer. The FDA has provisionally approved the trade name Prolia in these proposed indications, for which denosumab is administered twice yearly subcutaneously at a 60mg dose. The Prolia trade name is only for these indications and may not apply for other indications of denosumab.
Amgen has also submitted marketing applications for use of Prolia in the European Union, Canada, Switzerland, and Australia.
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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CONTACT: Amgen, Thousand Oaks
Kerry Beth Daly: (805) 447-3020 (media, osteoporosis)
Sarah Reines: (805) 447-9783 (media, osteoporosis)
Lisa Rooney: (805) 447-6437(media, oncology)
Arvind Sood: (805) 447-1060 (investors)
(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.
SOURCE Amgen Inc.