Still invoking caution

If FDA takes the advice of its Endocrinologic and Metabolic Drugs Advisory Committee, Johnson & Johnson's Invokana canagliflozin will be the first sodium-glucose cotransporter 2 inhibitor approved for diabetes in the U.S. But FDA's analysis of the cardiovascular safety data for the compound suggests the agency is still being very cautious in evaluating CV adverse events for diabetes therapies.

On Jan. 10, the Endocrinologic and Metabolic Drugs panel voted 10-5 that efficacy and safety data for Invokana support approval. Invokana was studied in the largest diabetes program to date, including seven Phase III efficacy trials and the Phase III CANVAS trial, a 4,327-patient CV outcomes trial...