Positive top-line results for Amgen's Prolia in patients receiving glucocorticoid therapy
US biotech major Amgen (Nasdaq: AMGN) has released positive top-line results from the primary analysis conducted in a Phase III randomized, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia (denosumab) compared with risedronate in patients receiving glucocorticoid treatment.
The study met all primary and secondary endpoints at 12 months. 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 and total hip, both in patients receiving continuing glucocorticoid therapy and in patients newly initiating glucocorticoid therapy.
Prolia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of bone-removing cells (osteoclasts). Prolia is approved and marketed in over 80 countries worldwide.
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