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

The repercussions of FDA’s 2008 guidance on cardiovascular risk evaluation in diabetes trials are still being felt in reviews of new agents. Pending applications include two GLP-1 agonists, the third review of a DPP-IV inhibitor, a possible first-in-class SGLT-2 inhibitor and a long-acting basal insulin, and safety is a major review issue for all of them.

Four years after FDA promulgated its guidance on assessment of cardiovascular risk in type 2 diabetes therapy trials, cardiovascular safety remains a major hurdle in reviews of new anti-diabetic agents.

FDA reviewers will address new agents in four major categories of recent diabetes advances – glucagon-like peptide 1 agonists, dipeptidyl...

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