UPDATE 3-US FDA panel rejects Debiovision, Salix drug

Tue May 19, 2009 10:51pm BST
 
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* Drug designed to treat bleeding in the esophagus

* Panel voted 14-0 benefits not shown to outweigh risks

* Salix shares fall 2.4 percent (Adds panelist, company comments; updates shares)

By Lisa Richwine

SILVER SPRING, Md., May 19 (Reuters) - A U.S. advisory panel on Tuesday rejected a Debiovision Inc drug after members said the company lacked enough evidence to show it was effective for treating a dangerous type of bleeding in the esophagus.

The Food and Drug Administration advisory committee voted 14-0 that currently available data failed to show the benefits of the drug, Sanvar, outweighed risks.

Salix Pharmaceuticals (SLXP.O) holds U.S. marketing rights for the medicine. Salix shares fell 2.4 percent to close at $9.81 on Nasdaq.

Panel members shared concerns voiced by FDA reviewers that Debiovision's most recent study had limitations, including the lack of a control group. The company compared the results with patients who received a placebo in an earlier trial.

Some panelists felt "there was some small level of improvement" shown mainly in one study, "but it's been complicated by the other studies that we can't completely interpret," said Dr. Lin Chang, the committee's chairwoman and co-director of the UCLA Center for Neurovisceral Sciences and Women's Health.  Continued...

 

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