Amgen Submits Supplemental Biologics License Application For Prolia ® (denosumab) In Glucocorticoid-Induced Osteoporosis

THOUSAND OAKS, Calif., July 31, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP).The sBLA is based on a Phase 3 study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment. Osteoporosis can be caused by glucocorticoid medications, which are prescribed to treat inflammatory diseases. Within the first three months of beginning glucocorticoid treatment, fracture risk increases by up to 75 percent, with bon...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news