FDA panel says no to Sanofi-Aventis' obesity drug

The pharmaceutical company, Sanofi-Aventis suffered a major setback Wednesday, when the U.S. Food and Drug Administration (FDA) advisory panel rejected company's bid to win approval for the so-called wonder drug, named “Rimonabant”, over concerns that it may increase suicidal thinking and depression.

The diet drug was in line for approval by experts who were due to decide the fate of this drug in a meeting on Wednesday. After hearing testimony on drug that has been delayed three times, the panel determined that it increases the risk of suicidal thoughts, even in patients without a history of depression.

France based Sanofi-Aventis didn't get a single vote yesterday in favor of its drug from a 14-membered committee of advisers to the FDA, which found that the weight lost in trials didn't justify the risks of psychiatric or neurological side effects.

The French pharmaceutical firm once again failed to prove the safe use of the drug rimonabant, the panel said.

"The potential market for this drug and the continued uncertainty about its risks, both known and unknown, lead to our concern about the use of this drug in the general population," said Dr. Amy G. Egan, an FDA staff medical reviewer.

Although FDA is not bound to follow its advisory panel's recommendations, it generally follows their guidance. The agency makes a decision on whether a product should be approved after evaluating all data and considering the recommendations of the advisory committee. The US health watchdog is expected to declare the result by the end of July.

“Rimonabant” which is already on the shelves in Europe (known as “Acomplia”), would have been sold in the United States as the prescription medication, called “Zimulti”, and as a rival to few other drugs meant to keep dietary fats from being absorbed by the body or develop a feeling of fullness in the brain in order to control the individual’s diet.

It works on the brain's endocannabinoid system to suppress hunger, The New York Times said Thursday. Studies cited in Wednesday's testimony suggest that tampering with the endocannabinoid system also increases psychiatric problems, the newspaper said.

The drug which helps patients to lose weight at the highest dose of 20 milligrams is meant for seriously overweight people with health problems and not for people looking at reducing a few pounds here and there.

Sanofi-Aventis, the maker of the drug claims on the basis of four-company sponsored drug trials which showed that people taking the required dose of the drug managed to lose an average of 14 pounds in three to six months as compared to ones taking placebo who could lose only 3½ pounds.

Rimonabant belongs to a new class of drugs called CB1 antagonists that acts directly on fat cells and blocks receptors in the brain that regulates appetite. It helps to create a feeling of fullness and as a result helps in controlling the diet, explained Louis Aronne, director of the Comprehensive Weight Control Center at New York-Presbyterian Hospital who was also a part of the trials.

Sanofi-Aventis, one of the five largest Pharmaceutical companies in the world after Pfizer, Bristol-Myers Squibb, Novartis and GlaxoSmithKline, is headquartered in Paris, France. The company engages in the research, development, manufacturing and marketing of pharmaceutical products for sale principally in the prescription market, but they also develop over-the-counter medication.

With inputs from United Press International.