FDA considers using clinical outcomes over surrogate markers in diabetes drug approval

The US Food and Drug Administration is considering whether to raise the bar to approval of diabetes drugs by requiring them to show effiacy on cardiovascular safety and increased life expectancy, measures which are much harder and costly to assess than those currently used.

In diabetes the body loses the ability to produce insulin, a hormone that helps control the concentration of sugar in the blood. To gain approval a new medicine for this lucrative disease currently needs to show an improvement in glycosylated hemoglobin, which indicates control of blood sugar over eight to 12 weeks. However, most diabetes sufferers ultimately die from CV complications and the FDA is deciding whether to insist on more direct measures of patient benefit rather than relying on surrogate endpoints like HbA1c.