FDA committee scotches Acomplia’s prospects
pharmafile | June 15, 2007 | News story | Sales and Marketing |Â Â Â
The future of Sanofi-Aventis' potential blockbuster Acomplia has been dealt a serious blow after an influential committee of FDA advisers voted unanimously against its approval.
The advisory committee's concerns about the drug's safety risks, in particular its chances of increasing suicidal behaviours, prompted shares in Sanofi to slump to a five-year low.
Although the FDA is not obliged to follow the committee's advice, it nearly always does, and the news has also thrown the anti-obesity drug's European licence into jeopardy with the EMEA now set to re-examine it.
It had been hoped Acomplia would prove to be not only a major breakthrough in treating the obesity epidemic but that it would also help prevent and treat diseases such as type II diabetes and heart disease.
However, the FDA has been approaching the drug with caution since its submission for approval back in April 2005. First, a potential indication in smoking cessation was dismissed and then Sanofi was asked to provide more data on Acomplia's potential side-effects.
A pooled analysis subsequently found the number of symptoms associated with a psychiatric adverse event reported by subjects was 427 in patients taking a 20-mg dose of Acomplia and 118 in the placebo-treated group.
A higher incidence of suicidality – specifically suicidal ideation – was found compared to placebo and the incidence of psychiatric adverse events, neurological adverse events and seizures also consistently higher.
Sanofi said in a statement it would work closely with the FDA to address the committee's recommendations.
Acomplia (rimonabant) was approved in Europe in June 2006, but doctors were instructed at the time not to give it to anyone with uncontrolled, serious psychiatric conditions such as depression.
Follow the US recommendations the EMEAs own advisory committee will review the data on the drug next week.
A final decision on the drug from the FDA is due at the end of July, but it is widely expect it not to be approved.
Analysts Lehman Brothers say Acomplia still has a chance for a US licence if Sanofi can use its ongoing CRESCENDO study to change the FDAs mind, but even if this proves possible they wouldnt anticipate it being launched in the US until 2011.
