Amgen Inc. has submitted a biologics license application (BLA) to the United States Food and Drug Administration for their investigative agent denosumab. The BLA is for the treatment and prevention of postmenopausal osteoporosis in women and treatment and prevention of bone loss among patients undergoing hormone ablation for breast or prostate cancer.
Denosumb is a fully human monoclonal antibody that specifically targets RANK Ligand, which is an essential regulator of osteoclasts. Denosumab is currently in late-stage trials; the BLA submission includes data involving more than 11,000 patients from six Phase III trials.
Amgen also intends to submit a marketing application for denosumab in these indications shortly in the European Union, Switzerland, Canada, and Australia.
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