Amgen’s Denosumab is a fully human monoclonal antibody in late stage clinical development that specifically targets Rank Ligand, the essential regulator of osteoclasts (the cells that break down bone).
Amgen claimed that this BLA represents the second marketing application for Denosumab that has been submitted to FDA. Denosumab is currently being reviewed under the trade name Prolia for conditions related to bone loss. For that application, the FDA has set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010.
Amgen said that it intends to submit marketing applications shortly in the EU, Switzerland, Canada and Australia, and also in Japan, working with its licensing partner, Daiichi-Sankyo. Amgen and Daiichi-Sankyo have a collaboration and license agreement for the development and commercialisation of Denosumab in Japan.
Roger Perlmutter, executive vice president of research and development at Amgen, said: “We believe that Denosumab will offer benefit to cancer patients suffering from bony metastases.
“Denosumab, administered monthly as a 120mg dose subcutaneously, demonstrated consistently similar or greater efficacy in clinical trials when compared to zolendronic acid, offering the potential to improve on the current standard of care.
“One advantage of Denosumab is that dose adjustments resulting from declining renal function are not necessary.”