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Obesity Drug Acomplia Wins Mexican Approval

Sanofi-Aventis SA, France's largest drugmaker, won clearance to sell the obesity treatment Acomplia in Mexico, the first approval of the product in North America.

The Mexican Ministry of Health approved the pill as an adjunct to diet and exercise for obese patients and overweight patients at risk of diabetes and heart disease, the Paris-based company said in an e-mailed statement today. Acomplia can also be used with standard treatments metformin or sulfonylurea to improve blood sugar levels in diabetics.

Mexico's approval of Acomplia to treat diabetes is a wider use than permitted by regulators in Europe, where the drug is only prescribed as a weight-loss treatment. Sanofi is still waiting for U.S. registration after submitting a response to open questions from the Food and Drug Administration last month.

Sanofi plans to introduce the drug in Mexico, where around 40 percent of the adult population is obese, at the start of next year, spokesman Jean-Marc Podvin said in a telephone interview. Sanofi shares rose 35 cents, or 0.5 percent, to 66.65 euros at the close of trading in Paris.

The company, Europe's second-largest drugmaker behind London-based GlaxoSmithKline Plc, needs U.S. approval to fulfill its expectations for as much as $3 billion in annual revenue for the product. Acomplia, approved in Europe since June, contributed 11 million euros ($14.1 million) to third-quarter sales.

Acomplia is the first diet drug to damp food cravings by blocking signals in the brain. In tests, patients showed improvements in blood-sugar levels and fat content that went beyond those attributable to weight loss. Lower blood sugar and fat may help prevent diabetes, a disease that can lead to amputations, blindness and death.

Source: http://www.azcentral.com/