News » October 2006

Diet Drug Acomplia approval could be delayed for 2007

October 10, 2006

An updated schedule for FDA advisory committee meeting has been posted on 10th October and the thing which needs to notice is that there is no sign that the panel will have any meeting with Sanofi regarding the approval of Acomplia drug in US in 2006. It was stated before that there is a hope that Rimonabant will get approval in 2006 itself.

The Schedule was for Endocrinologic and Metabolic Drugs Advisory Committee of FDA. It is a panel of medicine experts which can give advice and help FDA regarding the approval of diet drug acomplia in US. However it is not necessary for FDA to take their advice regarding the approval of drug.

After getting some serious side effect reports for the drugs which were approved by FDA before the committee is thinking to act more cautiously on the approval of drugs which effect on the brain receptors and acomplia also fall in this category.

No sign of meeting or discussions regarding acomplia in the schedule of FDA advisory committee panel emasculate Sanofi reiteration that they are still hoping for acomplia approval in US in 2006. It has been told that Sanofi will market Acomplia under the name Zimulti in US once it gets approval.

This is also a matter to look at Sanofi on its statement of US approval given last week. There is no clear picture available for anybody to know the status of acomplia with FDA regarding its sales in US. You can only refer to the results of trial done for acomplia.

Now there are no two ways to believe that FDA will show its movement for acomplia in 2007 only i.e in coming 12 months. We could have to wait till the second quarter of 2007 for the approval as per the financial analysts.

The more concern about the most anticipating diet drug rose when a investors got a note from one of the boosters of Sanofi stating that company had gone silent to investors, analysts and media and it would not say anything further till the announcement of quarterly financial results on 31st October.

Shareholders are becoming more skeptical from Sanofi’s decision of not to let anybody know about what’s going on with acomplia at FDA. US approval for acomplia is delaying from last 6-7 months at FDA.