Zimulti Application Withdrawn by Sanofi
Posted by
Jenny AlbanoJune 29, 2007 11:19 AMTags:
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Sanofi-Aventis, the world's third largest drug maker, withdrew its U.S. application for the weight loss drug Zimulti. The drug has been linked to suicidal thoughts and the advisory panel to the FDA voted that the agency should not approve Zimulti.
The medicine had an action date of July 26, but the application was withdrawn because there was not enough time to fix the problems with the diet drug. Sanofi says they are committed to getting the drug approved in the states and will meet with FDA officials to find out exactly what needs to be done to improve Zimulti's safety.
The pill would be the first of a new class of drugs that block receptors in the brain and organs linked to hunger signals. The so-called CB1 receptors, when working properly, help regulate food intake and how the body uses and stores fats and sugars. The medicine is approved in 42 countries and is sold in 20 as a treatment for obesity and overweight patients with associated heart risk factors, the company said.
It was found that patients who took one pill a day had significant weight loss. Zimulti along with a reduced calorie diet had patients losing 5% more weight than just a diet change alone.
The FDA panel did not want Zimulti approved because 3 patients committed suicide in clinical trials for the drug. There may have been a fourth suicide after the drug went on the market in other countries, but this has not been confirmed. Studies show that Zimulti patients were twice as likely to experience psychiatric side effects such as depression, anxiety, and suicidal thoughts than patients who took a placebo.
There are currently two FDA-approved prescription drugs for the long-term treatment of obesity: Meridia, an appetite suppressant, and Xenical, which limits the amount of fat the body can absorb. Meanwhile, Alli, a lower-dose version of Xenical that does not require a prescription, went on sale a few weeks ago.
Sanofi believes there is no evidence that Zimulti causes suicidal thoughts or actions.
For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.