Posted on 06/13/2007 9:47:08 PM PDT by neverdem
A drug once viewed as a possible magic bullet against obesity was rejected yesterday by a federal advisory panel because of worries that it causes neurological and psychiatric problems and increases the risk of suicide.
Although the drug, rimonabant, is already marketed in 37 countries, it is now unlikely that the Food and Drug Administration will approve its sale in the United States without additional safety data.
The advisory panel voted unanimously, 14 to 0, against recommending the drug, saying there was inadequate evidence of its safety. The F.D.A. is not required to follow the advice of such panels, but it typically does.
The panel’s vote was a blow to Sanofi-Aventis, the French company that makes the drug, which is sold in many countries under the brand name Acomplia. As the advisory committee finished voting, the company’s stock, which trades in this country as American depositary receipts, closed at $43.07, down $1.31 or 2.95 percent. It fell another $1.02 in after-hours trading.
Sanofi had expressed hope that the drug would be a $3 billion seller, with much of that market in the United States, a country with a growing obesity problem.
In a statement issued after the panel’s vote, the company said it would continue to work with the F.D.A. to address the panel’s concerns, which included worries about a high dropout rate in clinical studies of the drug, evidence of a doubling of psychiatric events and questions about whether the drug induced seizures.
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.”
The drug, which the company had planned to call Zimulti in the United States, works on the...
(Excerpt) Read more at nytimes.com ...
Bummer for Rosie and Michael Moore.
Oh no. Now I have to go to Tijuana for yet another drug.
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