Data from Pharmawand - Curated by EPG Health - Date added 11 October 2017
Amgen announced that the 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 28 July 2017 , is based on a Phase III 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 are used to treat many inflammatory conditions, can cause significant side effects, including bone loss. GIOP is the most common form of secondary osteoporosis, and it is estimated that one percent of the U.S. population is treated long-term with glucocorticoid medications. Within the first three months of beginning glucocorticoid treatment, fracture risk increases by up to 75 percent, with bone mineral density (BMD) continuing to decline significantly in the months that follow.