FDA Extends Review Time for Invokana MACE Indication
The Food and Drug Administration (FDA) is extending the review timeline of the supplemental New Drug Application (sNDA) for Invokana (canagliflozin; Janssen) by 3 months in order to have extra time to review additional data related to the reduction of major adverse cardiovascular events (MACE) in patients with type 2 diabetes mellitus.
The sNDA includes data from the Phase 3 CANVAS program which showed that the sodium-glucose co-transporter 2 (SGLT2) inhibitor reduced the combined risk of cardiovascular death, myocardial infarction, and nonfatal stroke in patients with type 2 diabetes. The application also includes the fixed-dose combinations, Invokamet (canagliflozin, metformin tablets) and Invokamet XR (canagliflozin, metformin extended-release tablets).
The FDA has set a new action date of October 2018 for this indication.
Invokana is currently approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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