The American drug regulator, the Food and Drug Administration (FDA), stated in a report yesterday that it may consider mandatory cardiovascular risk studies before considering any weight loss medication for approval, even if there is no evidence to suggest that there is any cardiovascular risk associated with the compound under consideration. This possible turn of events is apparently in response to previously approved medications having cardiovascular risks identified in post-marketing studies that were not picked up during clinical trials. A decision will be made on Thursday.
It is unlikely that any change in policy will have an impact on the approval of Qnexa, a decision on which will be made on 17th April. The company behind Qnexa has suggested that they carry out a trial assessing cardiovascular risk after they win approval, should they be successful. Qnexa are obviously not so quietly confident about the 17th of next month, having announced that they have recruited new employees in the areas of communications and marketing and they have also expanded the number of employees working directly on their Qnexa team.
Any mandatory cardiovascular risk study could be a very serious blow for this area of pharmaceutical research and development. It is also slightly disingenuous to suggest that some of the previously approved weight loss drugs that ended up causing heart problems did not raise red flags during clinical trial. Take Sibutramine. It was known that Sibutramine caused increases in blood pressure is some patients as well as increases in heart beats per minute; this is why we never prescribed it to patients with pre-existing cardiovascular risks. While we would never advocate a cavalier approach by regulators, we do feel that there must be a degree of proportionality when imposing new bars for approval.