The highly anticipated weight loss drug Acomplia (rimonabant) moved a giant step closer to the huge U.S. market on Nov. 9th with Mexico's approval of sale of the prescription diet pill.
Sanofi-Aventis, developer of the diet drug, said it expects to begin selling Acomplia in Mexico in January.
While Mexico itself is not viewed as a particularly large market for sales of what will be an expensive drug for most Mexicans, sale of Acomplia in Mexico potentially makes it easier for eager Americans to obtain it on day shopping trips to towns just across the border or on vacations.
Acomplia still is stalled at the U.S. Food and Drug Administration, and Sanofi provided no new indication whether the FDA now has it on a two-month track or a six-month track for a decision. Acomplia also has not been approved in Canada.
Interestingly, 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, where the Acomplia has been termed a "lifestyle" drug and turned down for insurance reimbursement in Germany.
Observers also were intrigued by Sanofi's news release announcing Acomplia's Mexican approval, which repeatedly used the name Acomplia.
Speculation has been rampant for some time that rimonabant, while on sale in Europe as Acomplia, would be marketed under some other name in the United States -- probably Zimulti.
It would seem strange, however, for Sanofi to market the drug under two different names within the three-country North American market, so perhaps rimonabant will ultimately make it to the U.S. as Acomplia afterall.
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