Use Of Pre-Approval CV Data From Ongoing Trial Gets Once-Over At Canagliflozin Panel
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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Currently the head of the Division of Metabolic and Endocrinology Products, Parks has handled drug safety controversies in diabetes and obesity products.
J&J is the first pharma company to bring an SGLT2 inhibitor to market, but its window of exclusivity in that class may be narrow, given that FDA is slated to assess two other SGLT2s later this year.
The repercussions of FDA’s 2008 guidance on cardiovascular risk evaluation in diabetes trials are still being felt in reviews of new agents. CV concerns earned Novo Nordisk’s long-acting basal insulin a “complete response” letter. Pending applications include two GLP-1 agonists and a possible first-in-class SGLT-2 inhibitor, and safety is a major review issue for all of them.