UPDATE: FDA panel votes in favor of outcomes over surrogate markers in diabetes drug approval

A US Food and Drug Administration advisory panel has recommended raising the bar to the approval of diabetes drugs by requiring them to show efficacy 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 panel voted 14 to two in favor of more direct measures of patient benefit rather than just relying on surrogate endpoints like HbA1c.

Standards for the approval of diabetes drugs were the subject of a two-day FDA meeting of outside experts convened on July 1 that came on the back of controversy surrounding two high-profile, long-term trials where drugs approved on the strength of benefit in surrogate endpoints did not improve life expectancy, reports the Wall Street Journal.