Sanofi-Aventis's obesity pill Acomplia faces a tough review from European drug safety experts this week, with data suggesting officials see issues over the drug's link with suicidal thoughts.
The European Medicines Agency (EMEA) safety assessment comes a month after a U.S. advisory panel recommended the drug should not be approved in the world's biggest market because it may increase depression and suicidal thinking.
That decision prompted France's Sanofi to withdraw its pending application to sell the medicine in the United States, dealing a major blow to what had been its biggest new drug hope.
In Europe, by contrast, Acomplia -- which is also known by the brand name Zimulti and generically as rimonabant -- has been on sale since last year.
Most industry analysts expect European officials to allow it to stay on the market but with stricter warnings that will limit its commercial potential. Acomplia use is already limited to patients with no history of major depression.
The EMEA's Committee for Medicinal Products for Human Use (CHMP) convened in London on Monday and is due to announce its decision on Thursday. It has a range of options available.
"They will recommend whatever they think is appropriate. It ranges from nothing to new warnings or other restrictions or contra-indications to suspension or withdrawal," an agency spokeswoman said.
Doing nothing seems unlikely.
More from Ben Hirschler at Reuters
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