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Tuesday, Sep 26, 2023

FDA Considers New Uses for Amgen’s Xgeva

Amgen Inc. announced Monday that the U.S. Food and Drug Administration has accepted an application to expand on Xgeva’s indicated uses. The Thousand Oaks biotech developed Xgeva for the prevention of bone fracture in patients with bone metases that are caused by solid tumors. With the application, Amgen is now asking that the drug will also be approved for patients with multiple myeloma. The announcement follows positive results of Phase 3 data on Xgeva, an injectable drug, which was announced two weeks ago. The study found that the drug significantly lowered rates of renal complications to 10 percent, compared to zoledronic acid at 17 percent. Zoledronic acid is currently used to treat bone issues in patients with multiple myeloma. Multiple myloma is a type of cancer formed by malignant plasma cells. They often cause tumors in the bone, which leads to frequent bone fractures. Amgen Inc. (AMGN) shares closed Monday up $2.67, or 1.6 percent, to $165.09 on the Nasdaq.

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