Biotech Values

[DewDiligence]

Not even close—panel nixes Acomplia by 14-0 vote.

http://www.nytimes.com/2007/06/14/business/14drug-web.html

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F.D.A. Panel Votes Against Weight-Loss Drug

June 14, 2007
By STEPHANIE SAUL

A drug once viewed as a possible magic bullet against obesity was rejected today by a federal advisory panel, which cited concerns that it increases the risk of neurological and psychiatric problems, including suicide.

Although the drug is already marketed in 37 countries under the name Acomplia, it is now unlikely that the Food and Drug Administration will approve its sale in the United States. The advisory panel voted unanimously, 14 to 0, against recommending the drug, saying there was inadequate safety data to support its use.

The F.D.A. is not required to follow the advice of such advisory panels, though it typically does.

The panel’s vote was a blow to Sanofi-Aventis, the French company that makes the drug.

As the advisory committee finished its voting, shares of Sanofi-Aventis, which trades in this country as American depositary receipts, closed at $43.07, down $1.31, or 2.95 percent. Sanofi had hoped the drug would be a $3 billion seller, with much of that market in the United States, which has a worsening obesity problem.

Dr. Jules Hirsch, an advisory committee member who is a research physician at Rockefeller University, summed up the sentiments of the other panelists. “I couldn’t in any way suggest that it be approved at the present time for use,” he said.

The drug, which the company had planned to call Zimulti in the United States, works on the brain’s endocannabinoid system. The system was discovered through research into marijuana, which works on brain receptors to give users the “munchies.”

By suppressing those receptors, Zimulti suppresses hunger. Clinical studies revealed that patients taking it lost about 5 percent of their weight.

But the same brain system also modulates depression, phobias, anxiety and post-traumatic stress disorder. Studies cited in testimony today suggest that tampering with the endocannabinoid system also increases such psychiatric problems, including suicidal thoughts.

“The potential market for this drug and the continued uncertainty about its risks, both known and unknown, lead to our concern about the use of this drug in the general population,” an F.D.A. staff medical reviewer, Dr. Amy G. Egan, told the panel.

The committee’s vote that there the safety data was inadequate came after Dr. Egan’s presentation, which indicated that the drug doubled a patient’s risk of psychological problems, including anxiety, depression, aggression and psychosis.

The committee also heard about data showing an increase in suicidal thinking among users of the drug, including four patients who did commit suicide while on it.
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