FDA Sets PDUFA Target Action Date of Feb. 3, 2018

Thousand Oaks, CA (Press Release) – Amgen (NASDAQ: AMGN) today announced that the U.S. 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. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Feb. 3, 2018.

"Multiple myeloma patients with fractures and other bone com­pli­ca­tions have a very poor prognosis. …