Amgen files for second US approval of bone drug denosumab, aiming for cancer patient market; FDA backs rotavirus vaccines

US biotechnology major Amgen says it has submitted a Biologics License Application (BLA) to the Food and Drug Administration for denosumab, a subcutaneous RANK Ligand inhibitor. The BLA submission summarizes clinical experience from nearly 6,900 patients across 18 clinical studies, including approximately 5,700 patients with advanced cancer in the three, pivotal, Phase III, head-to-head trials versus Zometa (zoledronic acid).

"We believe that denosumab will offer substantial benefit to cancer patients suffering from bony metastases," said Roger Perlmutter, executive vice president of R&D at Amgen. "Denosumab, administered monthly as a 120mg dose subcutaneously, demonstrated consistently similar or greater efficacy in clinical trials when compared to zoledronic acid, offering the potential to improve on the current standard of care. One potential advantage of denosumab is that dose adjustments resulting from declining renal function are not necessary," he noted.

Amgen intends to submit marketing applications shortly in the European Union, Switzerland, Canada and Australia, and also in Japan, working with its licensing partner, Daiichi-Sankyo.