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...