Shortly following FDA approval, the European Medicines Agency (EMA) also expanded denosumab indications to include glucocorticoid induced osteoporosis (GIOP). At the 27th of April denosumab had received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the EMA for the treatment of GIOP. The CHMP recommendation is supported by a Phase 3 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 CHMP positive opinion was reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU) and was approved at the 8th of June 2018. Specifically,, the indication is “for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture”.
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