BLA Submitted for Denosumab

Amgen Inc announced submission of a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for denosumab, an investigational RANK ligand inhibitor. Amgen is seeking FDA approval for treatment and prevention of postmenopausal osteoporosis in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA submission contains data from six phase III trials involving more than 11,000 patients.