Posted by Michael Wonder on 11 Jun 2018
European Commission approves Prolia (denosumab) for patients with glucocorticoid-induced osteoporosis
8 June 2018 - Third Indication in Europe for Prolia for the treatment of patients at increased risk of fractures.
Amgen today announced that 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 3 study that evaluated the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment.
