Amgen has filed with the FDA in mid of May, the biologics license application (BLA) submission which summarises clinical experience from nearly 6,900 patients across 18 clinical studies, including approximately 5,700 patients with advanced cancer in the three pivotal Phase 3 head-to-head trials versus Zometa (zoledronic acid).
FDA is expected to target an agency action within six months of the application submission date, resulting in a prescription drug user fee act (PDUFA) action date of Thursday, November 18, consistent with priority review guidelines.
Roger Perlmutter, executive vice president of R&D at Amgen, said: “In clinical trials, Denosumab has consistently demonstrated an ability to reduce the burden of complications from skeletal metastases, with a positive benefit-risk profile.”
Amgen has also submitted marketing applications in the European Union, Australia, Canada and Switzerland. In Japan, Amgen is working with Daiichi-Sankyo, its licensing partner.