Amgen submits BLA for denosumab subcutaneous RANK Ligand inhibitor

May 15 2010

Amgen Inc. (Nasdaq: AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) 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 3, head-to-head trials versus Zometa^® (zoledronic acid).

Bone metastases, the spread of tumors to the skeleton, are a serious concern for many patients with advanced cancer. When cancer spreads to the bone, the growing cancer cells weaken and destroy the bone around the tumor, often producing serious clinical consequences such as fractures, spinal cord compression, or the need to receive radiation or surgery to bone.  These events are collectively called skeletal-related events (SREs).  The RANK/RANKL pathway is believed to play a central role in cancer-induced bone destruction, regardless of cancer type. Denosumab is the first therapy to target this important pathway.

"We believe that denosumab will offer substantial benefit to cancer patients suffering from bony metastases," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.  "Denosumab, administered monthly as a 120 mg 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 potential advantage of denosumab is that dose adjustments resulting from declining renal function are not necessary."

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. Amgen and Daiichi-Sankyo Company, Limited, have a collaboration and license agreement for the development and commercialization of denosumab in Japan.

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.

SOURCE Amgen Inc.