Advisory Committee to Review Denosumab Data
THOUSAND OAKS, Calif., June 22 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has asked the company to participate in a meeting of the Reproductive Health Drugs Advisory Committee (RHDAC) on Aug. 13, 2009. The RHDAC will review data supporting the Biologics License Application (BLA) for denosumab, a RANK Ligand inhibitor for which Amgen is seeking approval for prevention and treatment of postmenopausal osteoporosis and prevention and treatment of bone loss in patients undergoing hormone ablation for either prostate or breast cancer.
'In the U.S., one woman in two over the age of 50 will experience an osteoporotic fracture in her remaining lifetime. Although osteoporosis treatments are available, there remains a need for other options that deliver robust efficacy and support adherence to therapy,' said Sean Harper, M.D., chief medical officer and head of Global Development at Amgen. 'Likewise, there is currently no approved treatment for the men and women receiving hormone ablation therapy for prostate or breast cancer who are at increased risk for bone loss and consequently fracture. We look forward to discussing the data from our denosumab trials in these settings with the members of the Committee.'
Amgen's BLA submission contains data from six Phase 3 trials involving more than 11,000 patients and approximately 13,000 patient years of exposure to denosumab. Two Phase 3 pivotal studies with fracture endpoints, in the osteoporosis and prostate cancer settings, demonstrated denosumab's ability to reduce the incidence of fractures, and all six studies showed denosumab's ability to increase bone mineral density at all skeletal sites measured. In the two pivotal studies with fracture endpoints, the incidence and types of adverse events with denosumab were similar to placebo. The most common adverse events in both the denosumab and placebo groups were arthralgia, back pain, hypertension, nasopharyngitis, constipation and pain in extremity.
The FDA has provisionally approved the trade name Prolia(TM) for denosumab in the proposed indications of treatment and prevention of osteoporosis in postmenopausal women, and treatment and prevention of bone loss in patients undergoing hormone ablation for prostate or breast cancer.
About Denosumab
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, as well as for its potential to delay bone metastases and inhibit and treat bone destruction across many stages of cancer.
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. 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)
Hormone Ablation-Induced Bone Loss
In the U.S., prostate cancer is the most common cancer in men and breast cancer is the most common cancer in women.
