Sanofi obesity drug faces tough EU safety review

By Ben Hirschler, European Pharmaceuticals CorrespondentMon Jul 16, 9:41 AM ET
Sanofi-Aventis SA'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.
Data compiled by the EMEA and presented to the U.S. Food and Drug Administration advisory panel last month underscores suspicions about Acomplia's link to psychiatric side effects.
After just one year on the market, the EMEA's post-marketing data showed there were 208 psychiatric adverse events reported with Acomplia, including 27 cases of suicidal thinking.
That compares with 14 cases of suicidal ideation with Roche Holding AG's obesity drug Xenical in the nine years since its 1998 launch and 15 cases with Abbott Laboratories Inc.'s Reductil/Meridia, which went on sale in 1999.
The figures are not directly comparable, however, since the Acomplia reports are a result of patient monitoring while those for Xenical and Reductil were unprompted.
Acomplia is the first in a new class of drugs that switch off the same brain circuits that make people hungry when they smoke cannabis.
Its unique mode of action and ability to reduce several risk factors for cardiovascular disease led to predictions it would become a multibillion-dollar-a-year blockbuster. In practice, however, sales to date have been modest.
Worldwide sales of Acomplia in the first quarter of 2007 totaled just 15 million euros ($20.7 million), down from 20 million in the fourth quarter of 2006.