FDA accepts Amgen's denosumab BLA

US biotechnology giant Amgen says that the Food and Drug Administration has accepted its submission and filed a Biologics License Application  for denosumab, an investigational RANK Ligand inhibitor. The indications  for which Amgen is seeking approval are the treatment and prevention of  postmenopausal osteoporosis in women and for the 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 submission  date, resulting in a Prescription Drug User Fee Act action date of  October 19. Due to the interdependency of the data across the  indications from more than 11,000 patients, both files will be reviewed  simultaneously.

Amgen adds that it has also submitted marketing applications for use of  denosumab for these indications in the European Union, Canada,  Switzerland and Australia.