European Commission approves Prolia for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.- Amgen.
The European Commission (EC) has approved a new indication for Prolia (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. The EC approval is based on the positive results of a Phase III study that evaluated the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment.
"Long-term glucocorticoid therapy is associated with a rapid and early decline in bone mineral density and increase in fracture risk," said Professor Dr. Willem F. Lems , researcher and rheumatologist, VU University Medical Centre , Amsterdam . "This approval provides a new treatment option to effectively counter the detrimental effects of glucocorticoid therapy on bone in patients at increased risk of fracture."
The EC approval is supported by a Phase III randomized, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment.
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