FDA Denies Effectiveness of Weight-Loss Drug Against Diabetes
The U.S. Food and Drug Administration is in the process of looking through three weight loss drugs on their agenda. Two of those have been rejected while the other is yet to be decided on.
One of the weight-loss drugs that got a thumbs down rating is Arena Pharmaceuticals’ Lorcaserin, a drug that claims they can be beneficial to obese diabetics. In fact, the company has conducted a Phase III trial to prove their candidate’s efficacy not just for losing weight but also for improving glucose levels, cholesterol levels, and other health factors.
Unlike the other two candidates for approval, Lorcaserin is a different drug in a sense that it acts on serotonin, which is a brain chemical that is associated with feelings of wellbeing and satisfaction. Reasons for disapproval include a very low percentage of weight loss at only 5-10 percent. It was also greatly considered that the drug has caused tumors to develop in rats, which may mean it can cause cancer in humans.
The Clinical TrialLorcaserin went through a clinical trial even before it had entered into the FDA approval process. The study followed diabetics for a period of a year, monitoring them constantly not just for their weight but for their blood sugar levels, cholesterol levels, and other health factors as well. After a year, the study showed weight improvement of 5% on 37.5 % of the participants who took 10mg of Lorcaserin daily. Only 16% of those participants who took the placebo were able to lose the same amount of weight. But what is more interesting is that Lorcaserin improved glucose levels, cholesterol and triglycerides in the participants.
According to Jack Lief, Arena Pharmaceuticals’ chief executive, “"Achieving weight loss in these patients can be difficult ... we are excited that the efficacy of lorcaserin was maintained in this diabetic population."
Then again, the study conducted on diabetics did not go without side effects. Symptoms of headaches, back pains, and upper respiratory infections occur. A small number of patients in both the Lorcaserin and control groups also developed heart valve problems or valvulopathy. But the company said that the “number of patients in each group was too small to detect statistically significant difference.”
According to FDA, the denial was based in part on “the weight-loss efficacy of lorcaserin in overweight and obese individuals without type 2 diabetes was marginal.” Still, FDA suggests that Arena submit their completed Phase III diabetic trial results as soon as they were complete. Additional clinical studies may also be required to obtain a stronger conviction and assessment of Lorcaserin’s benefit-risk profile before FDA makes a further review.