FDA accepts sBLA for expanded use of Prolia

The US Food and Drug Administration 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 by the drug’s maker Amgen (Nasdaq: AMGN) on July 28, 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.

The FDA first approved Prolia in June 2010 for the treatment of postmenopausal women at high risk for fracture. In September 2011, it was approved to treat bone loss in patients with prostate or breast cancer undergoing hormone ablation therapy followed a year later for the treatment of bone loss in men with osteoporosis at high risk of fracture.