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FDA Ignores Sanofi's Acomplia December 14, 2006 Acomplia is now expected before April end next year. There is likely to be a six month review period because of FDA's decision. The French drugmaker issued a statement saying that the US Food and Drug Administration has accepted its New Drug Application resubmission for Acomplia (rimonabant) to be a complete response to the agency's letter of February 17, demanding more information. Sanofi has just reported promising Phase III data on Acomplia which showed that the drug significantly lowered blood sugar levels while also reducing weight. However, its side effects, which included dizziness, nausea, depression and headaches, were worse than expected. Sanofi did not show whether its response to the FDA involved more clinical data being submitted, but analysts fear that the latest study is unlikely to satisfy the agency, particularly on the depression issue. Sanofi states that Acomplia has great potential to do extremely
well. This diet pill has already found a good market in a number
of European countries. But a lot will depend on the fact whether
it will be reimbursed. The government advisors in Germany have recently
suggested that the country's healthcare system should not reimburse
treatment with the drug, though Denmark, Ireland and Sweden have
backed such schemes.
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