The votes came in at 17 to 6 last week and the advisory panel to the FDA (Food and Drug Administration) has indicated to the regulators that weight loss drugs should go through clinical trials specifically gauging potential cardiovascular risk, even if there is no reason to suspect that a particular drug might have any effect on the cardiovascular system. Some members of the committee are worried about how this will affect obesity drug research since the carrying out of such trials is expensive and is furthermore a very lengthy process.
For obesity drugs that have not signalled any cause for concern in relation to cardiovascular illness, the FDA’s committee have decided that there is no need for such drugs to carry out a cardiovascular risk assessment pre-approval and rather can wait until after the FDA has made its decision before further risk assessment commences, however these assessments will be necessary.
Another recommendation made by the committee included that patients with a higher propensity for cardiovascular risk, such as those who are heavier for example, would be included in these studies since, at the moment, patients who are at the greatest cardiovascular risk are not included.
Qnexa is unlikely to be affected since the drug actually lowers blood pressure and so it is thought that it will be appropriate for Vivus to carry out a cardiovascular study after the treatment has been approved by the agency.
These are only the recommendations of the panel and the agency is not obliged to stick to the outcome of the vote.