Bigger Is Better, FDA Tells J&J Over Invokana Outcomes Trial
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Because of its preference for a strict MACE endpoint, rather than MACE+, for post-market cardiovascular outcomes trials of anti-diabetics, FDA thought J&J’s ongoing canagliflozin trial would take too long to reach the number of events needed due to its size. So J&J will start a new outcomes trial, bringing Invokana’s CVOT total enrollment to 10,000.