JAMA published a piece today on Sanofi's Acomplia. The results prompt great concern. Mainly, what seems most concerning are the following factors:
-- Psychiatric disorder differences in treated vs placebo groups 6.2% (n=76) vs 2.3% (n=14)
-- The 50% drop-out rate - although it was similar in placebo and treated groups, one assumes reason for drop outs is very different (placebo patients drop out because they didn't get the drug - it is unclear why the treated group drop out - even for Xenical and Meridia studies, drop out rate was closer to 20-30%)
The average weight loss is actually not all that impressive (under 5% of total weight) to us given the concerns. While the drug clearly works on metabolic risk factors for some, the psychiatric questions (which were well known before this publication) continue to concern.
We can't imagine that this could be viewed as a "positive" study by Sanofi, given the editorial. We can't see how based on results like these, the FDA would be willing to approve the drug, even for a very narrow label. And how could anyone call "obesity" very narrow?
We have also heard also heard that there is pressure on the FDA to approve an obesity drug, even though reimbursement will remain a major question. US sales of obesity drugs in 2005 (Roche's Xenical and Abbott's Meridia) were ~$120 million - both have major side effect (GI) issues and reimbursement is a hurdle for all drugs in this class.
More to follow~