Regulatory Decision Summary for JARDIANCE
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 Supplementary New Drug Submission (SNDS) was to gain approval for cardiovascular prevention indications and update the Product Monograph based on the results of the EMPA-REG Cardiovascular Outcomes Trial.
Why was the decision issued?
The results from the EMPA-REG Cardiovascular Outcomes Trial met the primary objective of demonstrating non-inferiority of empagliflozin to placebo with regard to a composite endpoint, Major Adverse Cardiovascular Events (MACE-3), defined as time to first event of cardiovascular (CV) death, non-fatal myocardial infarction, or non-fatal stroke in a population of patients with type 2 diabetes and established cardiovascular disease, using a non-inferiority margin of 1.3. EMPA-REG also demonstrated statistically significant reductions in the risk of MACE-3, CV death, all-cause mortality, hospitalisation for heart failure, and heart failure requiring hospitalisation or death from heart failure for empagliflozin compared to placebo.
A trend in favour of placebo was observed for the fatal/non-fatal stroke endpoint, but the results were inconclusive because the finding was not statistically significant and the imbalance was accounted for largely by events that occurred after empagliflozin had been discontinued.
Empagliflozin was also noted to increase serum levels of sodium, magnesium, and phosphate and to decrease serum bicarbonate levels.
Risk was mitigated by updating the Warnings and Precautions section to add to exercise caution in patients with risk factors for stroke, and the Adverse Drug Reactions section was updated to add events of urosespis and events showing imbalances in the EMPA-REG trial.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.