Summary
As indicated in the Tue 17 Mar 2009 Bloomberg article, the FDA has provided Sanofi-Aventis SA (NYSE:SNY) with a positive viewpoint for current NDA No. 22-425 [submission date: 31 Jul 2008], the New Drug Application for MULTAQ (dronderone hydrochloride). However, this positive viewpoint is not the same as FDA final approval for MULTAQ; rather, it is a nonbinding and nonfinal recommendation of a committee. Analysis of the public FDA documents on this matter indicate that the positive recommendation is both complicated and nuanced.
Analysis
The final two paragraphs of this article should not be overlooked. As stated there, the FDA does not always automatically follow an earlier positive viewpoint of an advisory panel with a subsequent FDA final approval for the pending drug product. Thus, future FDA final appoval for MULTAQ should not be assumed to be inevitable simply based upon this week's FDA activities. Noteworthy items include (a) reviewers' comments relating to the differences between the newer ATHENA study and the older ANDROMEDA study; and (b) the failure of prior NDA No. 21-913 [submission date: 10 Jun 2005], particularly the 29 Aug 2006 FDA not-approvable determination and related analysis.
