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FDA Accepts Submission and Biologics License Application for Denosumab
The FDA will target 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. Due to the interdependency of the data across the indications from more than 11,000 patients, both files will be reviewed simultaneously.
Amgen has also submitted marketing applications for use of denosumab for these indications in the European Union, Canada, Switzerland, and Australia.
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 PMO 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. Denosumab is also being investigated in rheumatoid arthritis.
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.
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. It has been reported that osteoporosis results in more hospital bed-days than stroke, myocardial infarction or breast cancer.
Hormonal Treatment-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. 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.