Amgen submits sBLA for Prolia in glucocorticoid-induced osteoporosis

Results from the Phase III 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.

Amgen has announced the submission of a supplemental Biologics License Application (sBLA) to the FDA for Prolia (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP).The sBLA is based on a Phase III study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment.

"Glucocorticoid-induced osteoporosis can lead to weakened bones and debilitating fractures," said Sean E. Harper, 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 III 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.