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Sanofi-Aventis suspends Acomplia sales in Europe

Sanofi-Aventis suspends Acomplia sales in Europe

French pharmaceutical company Sanofi-Aventis temporarily suspended sales of anti-obesity drug Acomplia in Europe, the company said Thursday, after health authorities said the drug's risks outweigh its benefits.
Sanofi-Aventis will "immediately" start talks with non-EU countries where the drug is available to have sales suspended there as well, the company said in a statement.
The decision follows a recommendation from the London-based European Medicines Agency, which earlier Thursday said a study had revealed obese or overweight patients taking Acomplia were at approximately double the risk of developing psychiatric disorders than those taking a placebo.
The agency's researchers also raised doubts over Acomplia's effectiveness in clinical practice, saying this was "more limited than was expected on the basis of the clinical trials," because patients generally take it for only a short period.
The agency urged doctors to stop issuing new prescriptions for Acomplia and to review the treatment of patients already taking it.
Sanofi-Aventis said Acomplia has been marketed in 18 EU countries since 2006. The company said it is "committed to provide additional evidence for the re-evaluation of the benefit/risk profile of Acomplia," which is used to treat patients with diabetes and cardiovascular disease.
The drug was prescribed in addition to diet and exercise for the treatment of obese and overweight patients with associated risk factors, the agency said in a statement.
Acomplia was once one of Sanofi-Aventis's potential blockbuster drugs with annual sales forecast of more than US$5 billion by 2010 _ but last year the drug's sales were only euro79 million (US$112 million).
Last year, the U.S. Food and Drug Administration rejected the drug after reviewing company studies that showed risks of psychiatric problems, including depression, anxiety and stress disorders.
Acomplia's development was overseen by Gerard Le Fur, who led Sanofi-Aventis' research and development department before becoming chief executive in January 2007. Le Fur was replaced in September after less than two years in the job, as investors' concerns grew over the company's ability to find new drugs to replace its blockbusters and tackle generic competitors when patents run out.
Sanofi-Aventis shares lost 30 percent of their value during Le Fur's tenure.
The shares fell as much as 4.2 percent after the Acomplia suspension was announced, but rebounded in late trading in Paris to close up 0.6 percent at euro45.70 (US$58.54).


Updated : 2021-10-16 20:15 GMT+08:00