BioCentury
ARTICLE | Politics & Policy

FDA to re-examine diabetes CVOT requirements

September 17, 2018 11:29 PM UTC

FDA is reconsidering its policy to require pre- and postmarket cardiovascular outcomes trials for diabetes drugs, and plans to hold an Oct. 24-25 meeting of its Endocrinologic and Metabolic Drugs Advisory Committee to discuss existing guidance for CV risks associated with the drugs.

Agency guidelines, finalized in 2008, require companies developing any diabetes compound to rule out at least a 80% increase in CV risk before approval based on pooled results from Phase II and Phase III trials. A CVOT is then required postapproval (see "FDA's Avandia Problem")...