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Amgen's Bone Cancer Drug Denosumab Gets Priority Review Designation From FDA - Update

Biotechnology company, Amgen Inc. (AMGN) on Friday reported that the U.S. Food and Drug Administration has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor, for the treatment of bone cancers to reduce skeletal related events in patients with cancer. Priority review designation is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.

The Biologics License Application 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, the company stated.

Amgen reported that bone metastases occur in more than 1.5 million patients with cancer worldwide. The economic burden of U.S. patients with bone metastases is estimated to be $12.6 billion annually.

Roger Perlmutter, executive vice president of Research and Development at Amgen commented, "Many cancer patients with skeletal metastases suffer debilitating complications, despite receiving the best available therapies. In clinical trials, denosumab has consistently demonstrated an ability to reduce the burden of complications from skeletal metastases, with a positive benefit-risk profile."

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. Denosumab is the first therapy to target the important pathway to cancer-induced bone destruction.

The company further revealed that, Amgen has also submitted marketing applications in the European Union, Australia, Canada and Switzerland. In Japan, Amgen is working with the company's licensing partner, Daiichi-Sankyo Limited and a submission is expected in the near future.

AMGN closed Friday's regular trading at $52.17, down $0.75, or 1.42% on a volume of 7.971 million shares on the Nasdaq.

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