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FDA accepts supplemental biologics license application for review for Prolia
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Amgen announced the FDA has accepted for review the supplemental biologics license application for Prolia in the treatment of glucocorticoid-induced osteoporosis.
According to a company press release, the supplemental biologics license application is supported by a phase 3 randomized, double-blind, double-dummy, active-controlled study that examined the safety and efficacy of Prolia (denosumab, Amgen) compared with risedronate in patients who received glucocorticoid treatment. Compared with risedronate, results showed denosumab led to greater gains in bone mineral density at the lumbar spine and total hip in patients who received continuing glucocorticoid therapy and in patients newly initiating glucocorticoid therapy. The release noted similar adverse events and serious adverse events between the treatment groups.
“We believe that Prolia can address a critical treatment need for patients with glucocorticoid-induced osteoporosis, which is the most common drug-induced form of the disease,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “We will continue to work closely with the FDA as they review our application and look forward to expanding Prolia’s benefits to patients with this serious condition that is often underestimated and untreated.”
A prescription drug user fee act action date has been set for May 28, 2018.
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