Seems Sanofi-Aventis still is not giving any guidance on when Acomplia (rimonabant) may be approved. It has been seven months with no word from the company.
Sanofi Remains Tight-Lipped - Forbes.com:
Other articles say that Sanofi is downplaying the impact of delays in getting Acomplia approved. My thought is if they can’t really say there is no impact and not give some sort of update regarding what the current situation is. They did say they are amassing data from European studies to show the drug is safe but they gave no details on why this was being done or what reservations the FDA may have had. The article does mention “secondary effects” and that to me sounds ominous (depending on what they are and how serious it may be). Although there is no data to directly support it, I think the US regulators are being more cautious than usual due to the so-called Vioxx effect.
It would be nice if Sanofi would give some indication of what reservations the FDA had and some sort of timeline as to when they may complete their amassing of data and submit it to the FDA. They almost certainly won’t get approval this year and I am doubtful if they could get approval in the first quarter of next year. Given the potential blockbuster nature of this drug, it will be interesting to see how this story develops and when (or if) they will get US approval.
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