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Diabetes Drug Report for November 2006 -- News About Diabetes
 
Mexico Approves Diet Drug Acomplia for Treatment of Type 2 Diabetes
 

The efforts of Sanofi-Aventis to position Acomplia (rimonabant) as not just a diet drug but a medication helpful in treating a variety of cardiometabolic conditions got a small boost on Oct. 10th when Mexico became the first country to approve the prescription drug with a type 2 diabetes indication.

The Mexican Ministry of Health approved the pill not only as an adjunct to diet and exercise for obese patients or overweight people at risk of diabetes and heart disease, but also said Acomplia can be used with standard treatments metformin or sulfonylurea to improve blood sugar levels in diabetics.

The diabetes language is broader than the indication approved by regulators in Europe. Acomplia still has not been approved for sale in the United States by the U.S. Food and Drug Administration.

Meanwhile, more positive news appears to be on the way about the drug's benefits in aiding glycemic control in newly diagnosed type 2 diabetes patients.

Results of the so-called Serenade trial (Study Evaluating Rimonabant Efficacy in Drug Naive Diabetic Patients), a six-month study which began in March 2005 with 281 participants, are scheduled to be presented next month at the 19th World Diabetes Congress in Cape Town, South Africa.

The primary objective of this fairly small trial was to assess whether giving newly diagnosed type 2 diabetics Acomplia -- together with a reduction in caloric intake of 600 calories a day -- brought their blood glucose as measured by the HbA1C test under better control than reducing caloric intake alone.

"This is a key study . . . the first study of treatment of patients suffering from type 2 diabetes," said Hanspeter Spek, Sanofi's head of pharmaceutical operations. "It will be presented at an international congress. We are looking forward to the presentation with a lot of optimism and confidence."

Pressed by analysts about the 99.99 percent probability that Sanofi already is well aware of the results of the study, Spek said: "It is good practice not to talk about the study until it is exposed to the professional audience and the public.

"Of course we are looking forward to this study with a lot of confidence," he repeated. "It is a landmark study."

So once again, the news from Sanofi's clinical trials of Acomplia appears to be extremely positive.

 
 
 
 
 
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Last Updated: 11/25/2006 Copyright 2004-2006 Medical Week News, Inc. All Rights Reserved