THOUSAND OAKS, Calif., Aug. 13 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) issued the following statement on the outcome of today's meeting with the U.S. Food and Drug Administration (FDA) Advisory Committee for Reproductive Health Drugs (ACRHD) to review the potential use of Prolia(TM) (denosumab) for the prevention and treatment of postmenopausal osteoporosis and the prevention and treatment of bone loss in patients undergoing hormone ablation for either prostate cancer or breast cancer.
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.
About Osteoporosis
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.
