
Amgen’s Prolia achieves positive top-line Phase III results after 12 months
pharmafile | August 30, 2016 | News story | Manufacturing and Production, Research and Development | Amgen, Prolia, denosumab, phase III
Amgen has announced that its drug Prolia (denosumab) generated positive Phase III results investigating its safety and efficacy in patients receiving glucocorticoid treatment compared to risedronate, meeting all of its primary and secondary endpoints after 12 months.
A total of 795 patients were enrolled in the 24-month study, treated with Prolia 60 mg subcutaneously every six months compared with oral risedronate 5 mg daily in two patient subpopulations: 505 patients receiving continuing glucocorticoid therapy and 290 patients newly initiating the same therapy.
The data showed that treatment with Prolia for 12 months, compared to risedronate, led to significantly greater gains in bone mineral density (BMD) at the lumbar spine (4.4% vs 2.3% for those continuing therapy and 3.8% vs 0.8% for new initiates) and total hip (2.1% vs 0.6% and 1.7% vs 0.2%).
“The impact of glucocorticoid therapy on bone strength is frequently underestimated, and often leads to increased bone loss and ultimately, a fracture,” said Sean E. Harper, executive vice president of Research and Development at Amgen. “We are excited that these data support the potential for Prolia use in patients with glucocorticoid-induced osteoporosis, the most common drug-induced form of the disease.”
Matt Fellows
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