FDA advisory committee to consider CV studies for diabetes drugs

FDA will ask an advisory committee this week to consider whether cardiovascular outcomes trial requirements for diabetes drugs should be diminished or discarded, according to draft questions released ahead of the Oct. 24-25 meeting.

Intensified CVOT requirements imposed in a 2008 guidance have not identified any CV risk, William Chong, acting director of FDA’s division of metabolism and endocrinology products, noted in a memo to members of the Endocrinologic and Metabolic Drugs Advisory Committee. “We now have eight clinical trials conducted under the guidance,” Chong wrote, and none have found excess CV risk. “Notably, some of the trials have shown a reduced risk for adverse cardiovascular events,” he added...