Experts on obesity including representatives of the Obesity Society and the American Society for Metabolic and Bariatric Surgery, to name but a few organisations involved, met with an FDA (Food and Drug Administration) spokesperson on Tuesday to discuss the future of the weight loss drug market as prompted by the rejection of three hopeful weight loss drugs this last 6 months, Contrave, Qnexa and Lorcaserin. Contrave was the closest to the finish line with the advisory panel recommending the approval of the drug. The FDA rejected the drug in the end despite normally going with the advice of its panel because they said they required more information on cardiovascular outcomes.
The spokesperson for the FDA was clear about the requirements for the approval of weight loss drugs and stated that in clinical trials, pharmaceutical companies must show that 30% of people at least lose 5% of body weight. Furthermore, one year later, the deviation in the mean weight loss between the control group and the group taking the drug must be at least 5%.
She went on to say that a 5% weight loss is not a staggering loss and it might not sway the FDA into putting a drug on the market due to the risk factors associated with such drugs and the risk is greater the more widely the drug is likely to be used. The spokesperson puts the weight of the decision into perspective when she says that when assessing a drug’s potential for market, the FDA is potentially approving a medication to be used by one-third of the population.
A clinical professor of medicine at Cornell University was also present and suggested that focusing on how obesity effects health should be the next step. For example, a lot of people cannot tolerate treatment for sleep aponea but if clinical trials could prove that managing their weight with the aid of weight loss drugs could relieve the sleep apnea, this could be a way of moving forward.
Discussion will continue in this area but the obesity experts were happy to have had the opportunity to engage in such a discussion with the all-powerful FDA. We will be updating the weight loss news page with the latest in pharmaceutical news. For now, Vivus who have presented more data on their weight loss drug, Qnexa, are currently being assessed in the United States in the EU. We will have more news on this later this year.