Amgen up as Xgeva closes in on expanded indication
US biotech Amgen (Nasdaq: AMGN) closed 1.6% up on Monday at $165.09 after news of further progress relating to its monoclonal antibody, Xgeva (denosumab).
The US Food and Drug Administration (FDA) has accepted the Xgeva (denosumab) supplemental Biologics License Application (sBLA) that seeks to expand the currently-approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors, to include patients with multiple myeloma. A Prescription Drug User Fee Act (PDUFA) action date has been set by the FDA of February 3, 2018.
Sean Harper, executive vice president of research and development at Amgen, said: “Multiple myeloma patients with fractures and other bone complications have a very poor prognosis.
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