The FINANCIAL — Amgen on July 31 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 bone mineral density (BMD) continuing to decline significantly in the months that follow, accrding to Amgen.
“Glucocorticoid-induced osteoporosis can lead to weakened bones and debilitating fractures,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “With this submission and future approval, we look forward to bringing the benefits of Prolia to patients living with this often overlooked and untreated form of osteoporosis.”
Results from the Phase 3 study included in the sBLA submission showed that treatment with Prolia for 12 months led to statistically significant greater gains in BMD at the lumbar spine and total hip compared to risedronate, both in patients on sustained glucocorticoid therapy and in those newly initiating glucocorticoid therapy. Adverse events (AEs) and serious adverse events (SAEs) were similar across treatment groups and consistent with the known safety profile of Prolia.