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Acomplia likely to be launched in Europe or Mexico
prior to the U.S. With the delay of approval of Acomplia (rimonabant) by FDA for sale of the weight loss drug in the U.S., Sanofi-Aventis, the maker of the drug is apparently hoping to launch the highly anticipated weight-loss drug in Europe and Mexico during the second half of this year. Sanofi management, at their meeting with analysts on Feb. 24th, presented a slide show that included a planned launch schedule of Acomplia, the weight loss drug, in the United Kingdom, Ireland, Germany, Sweden, Denmark, Finland and Mexico where Sanofi is expected to begin selling the drug in 2006. On the other hand, Sanofi is still expecting to launch Acomplia in the U.S. before the end of the year 2006. Although Sanofi is planning to launch the drug in Europe prior to the U.S. but till now not a single word is uttered by Sanofi about where Acomplia stands in the European Medicines Agency (EMEA) approval process. An application was submitted to EMEA's Committee for Medicinal Products for Human Use at about the time it went to the FDA but no detail information is available in this matter. Sanofi also has not said anything about the submission of a marketing application to the Mexican regulatory authority (General Directorate for the Control of Medicinal Products and Technologies Related to Health). Previously, Sanofi was expecting Acomplia to be approved by the FDA prior to its approval in Europe, but the FDA's decision 10 days ago to delay action pending resolution of unspecified issues has put the timing of approval in the U.S. very much in doubt. As a result, now it is more than likely that the
obese people of Europe and Mexico are going to benefit from the
diet pill Acomplia before the people of the U.S. Read the complete news story here: http://www.acompliareport.com
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