It sounds too good to be true: rimonabant fda approval

A pill that helps you lose weight, quit smoking, and reduce the cardiovascular risks for diabetes and heart disease.Sanofi-Aventis SA’s new treatment, Acomplia, also known as rimonabant, has shown promise in a half-dozen clinical trials in curbing the cravings that make people hungry and reach for a cigarette.The experimental drug, which works differently from other weight-loss medicines, could be approved by the Food and Drug Administration as soon as this month. And industry analysts predict it could become the world’s first blockbuster antiobesity treatment, with annual sales of 2 billion to 4 billion euros, or $2.4 billion to $4.8 billion.

In studies, a 20-milligram dose once a day helped patients lose 5 percent to 10 percent of their weight in a year, raise good HDL cholesterol, lower triglycerides, and improve blood sugar and blood …

The weight-loss drug rimonabant should not be approved by the U.S. Food and Drug Administration because of continuing concerns about increased risks for suicidal thoughts among some users, an advisory panel concluded Wednesday.The unanimous 14-0 vote followed another unanimous vote by the panel that drugmaker Sanofi-Aventis had failed to prove the safety of its drug, the Associated Press reported.”There is a reasonable suspicion we better learn some more and watch this affair more closely before we launch into massive use of this drug,” said panelist Dr. Jules Hirsch, of The Rockfeller University.

While the rimonabant FDA approval isn’t bound to follow the recommendations of its advisory panels, it typically does.
Rimonabant has been touted by Sanofi-Aventis as a wonder drug that aids in weight loss and also helps people stop smoking, but the drug has been linked to increased risk of suicidal thoughts among some …

For now, Sanofi-Aventis S.A.’s potential wonder drug Acomplia may be approved only as a weight-loss drug.In a negative development for the French drugmaker, the Food and Drug Administration declined yesterday to approve the treatment, known by the chemical name rimonabant, as a smoking-cessation medicine.The FDA sent Sanofi-Aventis an “approvable” letter for Acomplia to be used for weight management. An approvable letter means the company must meet certain conditions before a product can be sold.

The FDA would not comment on the reasons for its decision, or specify the conditions that the company will have to meet.The French drugmaker - which has its U.S. headquarters in Bridgewater, N.J., and employs 1,000 at a drug-development center in Malvern - told investors Jan. 30 that if Acomplia received final marketing approval this month, the drug could be on the market by June 30. But …

The Food and Drug Administration has told drug maker sanofiaventis that it will approve the company’s Acomplia (rimonabant fda approval) for weight loss but not for smoking cessation.