Amgen granted FDA priority review designation for denosumab BLA

Amgen (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor, for the treatment of bone metastases to reduce skeletal related events (SREs) in patients with cancer. Filed in mid-May with the FDA, the Biologics License Application (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).

Priority review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Consistent with priority review guidelines, the FDA will 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.

"Many cancer patients with skeletal metastases suffer debilitating complications, despite receiving the best available therapies," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen.  "In clinical trials, denosumab has consistently demonstrated an ability to reduce the burden of complications from skeletal metastases, with a positive benefit-risk profile.  We believe that this priority review designation underscores the potential for denosumab to provide a meaningful advance over the current standard of care for patients with metastatic bone disease."

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 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.

Amgen has also submitted marketing applications in the European Union, Australia, Canada and Switzerland.  In Japan, Amgen is working with our licensing partner, Daiichi-Sankyo Limited and a submission is planned in the near future.