Use Of Pre-Approval CV Data From Ongoing Trial Gets Once-Over At Canagliflozin Panel
Executive Summary
There is no statistical reason not to allow a single trial to provide pre-approval and post-approval cardiovascular hazard ratios for a diabetes drug, FDA says, but Janssen’s canagliflozin would be the first. The Endocrinologic and Metabolic Drugs Advisory Committee backed approval 10-5.
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