Sanofi-Aventis Gives Up On Acomplia
Make a commentBy Ed Silverman // June 29th, 2007 // 12:31 pm
The drugmaker plans to withdraw its application with the FDA to sell its controverial diet pill in the US, according to a statement issued a short while ago. Nonetheless, the drugmaker vows to resubmit its request “at a future date…Sanofi-Aventis is committed to making all efforts necessary to make rimonabant available to patients in the US.”
This is hardly surprising. An FDA advisory committee panel earlier this month unanimously voted against recommending the diet drug after hearing evidence that Acomplia increases the risk of suicidal behavior - three patients committed suicide during trials. Sanofi-Aventis didn’t help its cause by failing to convince the panel that the pill is safe.
The decision was a huge blow to the drugmaker, which already sells the diet pill in other countries, but was counting on the huge US market to make Acomplia a blockbuster and revive its growth.