Sanofi Stumbles After Drug Setback

In December, the FDA granted an accelerated review for Champix, which means the agency expects to act within six months. Pfizer also submitted an application to the European Union in November.

Hauber, of Bear Stearns, says Champix might have a research edge anyway because it was tested vs. Zyban, from GlaxoSmithKline, while Acomplia was only tested vs. the placebo. Champix had a statistically significant advantage over Zyban in terms of patient quit rates, Hauber says.

The FDA's rejection of Acomplia as a stop-smoking drug doesn't kill all chances of a comeback. Sanofi-Aventis will probably have to conduct more clinical trials, and if Acomplia is approved for weight management doctors are allowed by law to prescribe it for any condition.

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