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June 29, 2006
Well, although Sanofi-Aventis still hasn't been very forthcoming on their FDA problems, their CB-1 antagonist Accomplia (rimonabant) has now been approved in Europe, and is already on sale in the UK. (S-A still say that they expect it to make it through in the US by the end of the year).
This article from Bloomberg is an excellent summary of the situation. No new obesity drugs have been approved for almost ten years, and potential sales of a safe and effective one are almost impossible to estimate. But there's room to argue about how effective rimonabant is, and (as with any drug) there's always room to argue about safety. And that's particularly true in what some people are already calling the post-Vioxx era.
The article makes some of the same points that I've made here before: new therapies and new mechanisms have risks, and there is no way that we (the drug industry and the regulatory authorities) can get rid of them. We can test for the big ones and read the signs for the smaller ones, but if a new drug is going to taken by millions of people for long periods, things will happen that no one ever saw during the clinical trials.
I hope, for Sanofi's sake and everyone else's, that there's nothing weird lurking down in the statistical weeds this time. But you can be absolutely sure that the company is holding its breath. We all do. It doesn't help.
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