Regulatory Decision Summary for ADREVIEW
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 the submission was to seek approval for expanding the indications for AdreView, a diagnostic radiopharmaceutical that is currently authorized for the detection of pheochromocytoma or neuroblastoma. The proposed indication is for the assessment of sympathetic innervation of the myocardium in patients with heart failure.
Why was the decision issued?
In the clinical management of heart failure (HF) patients, there is a need for improved risk stratification. The results of the extended MBG311 and MBG312 studies demonstrate that AdreView imaging and quantitation of cardiac adrenergic neuronal activity provides additional insight and prognostic information beyond demographic and clinical factors. Multivariate analyses performed using models that include established risk prediction factors demonstrated that the AdreView H/M ratio is a significant additional predictor of all-cause mortality (HR = 0.23; p = 0.016). Therefore, AdreView may be used as an adjunct test to other established tools to further assess the risk of mortality. The safety data from the pivotal studies were consistent with the safety profile previously established in clinical trials and post-market experience which indicate that AdreView is generally safe and well tolerated. Based on the potential clinical benefit of AdreView in combination with its good safety profile, the benefit/risk ratio is favorable.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.