Sanofi-Aventis says that no decision on US approval for its obesity drug
Acomplia is likely before the end of April next year.
The French drugmaker issued a statement saying that the US Food and Drug Administration has accepted its New Drug Application resubmission for
Acomplia (rimonabant) to be a complete response to the agency’s letter of
February 17, demanding more information. This now triggers a six-month review period.
Sanofi has just reported promising Phase III data on Acomplia which showed that the drug significantly lowered blood sugar levels while also reducing weight. However, its side effects, which included dizziness, nausea, depression and headaches, were worse than expected.
Sanofi did not indicate whether its response to the FDA involved more
clinical data being submitted, but analysts fear that the latest study is
unlikely to satisfy the agency, particularly on the depression issue.
Acomplia is already on the market in a number of European countries and
Sanofi believes it has blockbuster potential. However, much will depend on
whether it will be reimbursed. Sweden, Denmark and Ireland have backed
such schemes, but government advisors in Germany recently recommended that the country’s healthcare system should not reimburse treatment with the drug.