Sanofi Obesity Pill Set for European Safety Assessment
July 18, 2007
Sanofi-Aventis’ obesity drug Acomplia is facing a demanding European safety assessment following the release of data which links the drug to suicidal thoughts.
The European Medicines Agency (EMEA) is reviewing Acomplia a month after US regulators rejected the drug on the grounds that the drug’s benefits failed to outweigh side-affects, including suicidal thoughts and depression.
The company spent more than 10 years developing the drug.
In Europe, Acomplia has been on sale since last year. It is also marketed under the brand name Zimulti. European officials are expected to allow it to stay on the market, but with stricter warnings, Reuters said.