Amgen has submitted a biologics license application to the US Food and Drug Administration (FDA) for Denosumab, a subcutaneous Rank Ligand inhibitor, which summarises clinical experience from nearly 6,900 patients across 18 clinical studies.
The studies include approximately 5,700 patients with advanced cancer in the three, pivotal, Phase 3, head-to-head trials versus Zometa (zoledronic acid).
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).
Denosumab is currently being reviewed under the trade name Prolia for conditions related to bone loss.
The FDA has set a corresponding Prescription Drug User Fee Act (PDUFA) action date of 25 July 2010.
Amgen said that it intends to submit marketing applications 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.
“We believe that Denosumab will offer benefit to cancer patients suffering from bony metastases,” Amgen vice-president of research and development Roger Perlmutter said.
“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,” Perlmutter said.