The FDA also said that it would not approve the drug in an additional indication for smoking cessation. This is another blow for Sanofi although the drug is primarily considered to be a weight loss medication.
The nature of the additional information being requested by the FDA was not made public, making it difficult for analysts to predict just how much of a delay the approvable letter will constitute. Some analysts are still hopeful that the drug will reach the market before the end of the year, but others warn that it could be delayed into 2007.
The approval of Acomplia is particularly important to Sanofi-Aventis as the company faces loss of revenue as patents covering its key drugs expire, or are challenged by generic drugmakers.
Acomplia works by suppressing certain pathways in the brain that are associated with hunger. The company previously predicted that the drug could have annual sales in excess of $3 billion.