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2013 Diabetes NMEs Span Classes, But Safety Is A Review Issue For All

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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.


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