Regulatory Decision Summary for Prolia
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this submission was to obtain approval for the addition of the following indication for Prolia: treatment and prevention of glucocorticoid-induced osteoporosis in women and men at high risk of fracture.
Why was the decision issued?
The safety and efficacy of Prolia for the treatment and prevention of glucocorticoid-induced osteoporosis were assessed in a randomized, double-blind, active-controlled, Phase 3 clinical trial. In women and men at high risk for bone fracture undergoing high-dose long-term glucocorticoid therapy, Prolia treatment for one year (60 mg by subcutaneous injection every 6 months) resulted in greater increases in bone mass, measured as bone mineral density, compared to risedronate treatment (5 mg daily). The overall safety profile of Prolia was similar to that observed in previous studies of Prolia. The benefit/risk ratio of Prolia to increase bone mass in the treatment and prevention of glucocorticoid-induced osteoporosis is considered favourable. Long-term safety of Prolia in this patient population will continue to be monitored using the previously established risk management plan.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.