Sanofi-Aventis withdraws rimonabant NDA
Sanofi-Aventis said Friday it has decided to withdraw its New Drug Application (NDA) for weight-loss treatment rimonabant in the US.
The decision came just a week and a half after an advisory panel of outside experts recommended that the FDA not approve rimonabant because the drug’s possible connection to suicidal behavior and other psychological side effects in some patients.
Although the FDA does not have to follow the advice of its outside expert panels, it often does. The FDA was scheduled to issue a final decision on the drug July 27.
Sanofi-Aventis said in a statement it will work towards re-submitting rimonabant at a future date.
Sanofi-Aventis had hoped rimonabant, also known by the brand names Acomplia and Zimulti, would be the drugmaker's next billion-dollar earner. But Sanofi's own clinical studies have raised concerns among regualtors about an increased rate of psychiatric adverse events among patients taking rimonabant including depression, anxiety and insomnia.