THOUSAND OAKS, Calif., Feb. 18 /PRNewswire-FirstCall/ -- Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted Amgen's submission and filed a Biologics License Application (BLA) for denosumab, an investigational RANK Ligand inhibitor. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women and treatment and prevention of bone loss in patients undergoing hormone ablation therapy for either prostate or breast cancer.
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.
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