Biologics
Amgen Submits Biologics License Application for FDA Approval of Denosumab in Women With Postmenopausal Osteoporosis and in Patients Undergoing Hormone Ablation for Either Prostate or Breast Cancer
Published in Medical Letter on the CDC and FDA, January 11th, 2009
Amgen Inc. (NASDAQ:AMGN), announced submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) 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 for either prostate or breast cancer. The BLA submission contains data from six Phase 3 trials involving more than 11,000 patients.
"Two Phase 3 pivotal studies with fracture endpoints, in the PMO and prostate cancer settings, demonstrated denosumab's ability to reduce...
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