FDA Accepts Supplemental Biologics License Application For Prolia ® (Denosumab) In Glucocorticoid-Induced Osteoporosis

Glucocorticoid-Induced Osteoporosis is the Most Common Form of Secondary Osteoporosis THOUSAND OAKS, Calif., Oct. 9, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). The sBLA, which was submitted on July 28, 2017, is based on a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid treatment. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2018. Glucocorticoid medications, which ...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news