The US Food and Drug Administration (FDA) has accepted Amgen’s submission and filed a Biologics License Application (BLA) for denosumab, the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK ligand, an essential regulator of osteoclasts. 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 10 months of the application’s submission date, resulting in a Prescription Drug User Fee Act (PDUFA) action date of October 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.