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FDA: Biologics License Application submitted for denosumab
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Agmen recently submitted a supplemental Biologics License Application to the FDA for denosumab for the treatment of people with glucocorticoid-induced osteoporosis, according to a company press release.
The application is based on data from a phase 3 study comparing the safety and efficacy of the RANKL inhibitor denosumab (Prolia) with the bisphosphonate risedronate in people receiving glucocorticoid treatment. Study results revealed that denosumab treatment for 12 months led to significantly greater gains in bone mineral density at the lumbar spine and total hip compared with risedronate in adults on sustained glucocorticoid therapy and those newly initiating glucocorticoid therapy. Reported adverse events and serious adverse events were similar between the two groups.
“Glucocorticoid-induced osteoporosis can lead to weakened bones and debilitating fractures,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “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.”