FDA panel backs shifting diabetes CV safety studies to premarket

An FDA advisory committee Thursday recommended the agency modify diabetes drug safety guidelines to soften or eliminate requirements for postmarket cardiovascular outcomes trials of new Type II diabetes drug candidates, and replace them with a mandate for premarket studies powered to detect signals of CV risk.

The split 10 to 9 vote of the Endocrinologic and Metabolic Drugs Advisory Committee reflected the confusing nature of the sole voting question, rather than a lack of consensus among committee members. ...