The highly-anticipated diet drug Acomplia (rimonabant) was approved on June 21st for sale in all 25 European Union countries, and developer Sanofi-Aventis announced that the weight-loss drug will go on sale in July in the United Kingdom.

The European Commission authorized sale of the prescription drug for use in treating obese patients with a body mass index (BMI) of 30 or more, or for treating patients with a BMI of at least 27 who also have type 2 diabetes or the prediabetic condition dyslipidaemia.

"The approval of Acomplia in the European Union is important news for obese and overweight patients with additional cardiometabolic risk factors such as type 2 diabetes or dyslipidaemia who will now have access to an innovative treatment option,” said Sanofi CEO Jean-François Dehecq.

Significantly, the label approved by the European Commission states that an estimated 50 percent of the improvements that occurred in clinical trials in HbA1c (a measure of blood-sugar control), HDL-cholesterol and triglycerides were beyond that which could be attributed simply to weight loss.

Sanofi said that the launch of Acomplia in the United Kingdom would be followed during the second half of 2006 by launches in Denmark, Ireland, Germany, Finland and Norway.

The company provided no new information today on the status of the approval process at the U.S. Food and Drug Administration, where Acomplia has been bogged down awaiting resolution of unspecified issues since February.

It continues to seem highly unlikely that Acomplia will make it to the market in the United States until at least 2007.

Acomplia, discovered and developed by Sanofi, is the first in a new class of drugs called CB1 blockers, which block receptors in the brain. Several other large pharmaceutical companies, including Merck, Pfizer and Lilly, also have weight-loss drugs that affect CB1 receptors at various earlier stages of development.

Sanofi said in its announcement today that those likely to gain the most benefit from Acomplia are obese patients with a large waist circumference who also have diabetes and/or dyslipidemia.