Tuesday, August 30, 2005

Tysabri update

I've got the WSJ article (by Sylvia Pagan Westphal) now. Here's the gist:

Stephen Harr, a Morgan Stanley analyst, prepared a note based on adverse-event (AE) reports submitted to FDA, which the analyst obtained by a request under the Freedom of Information Act. In addition to the already-publicized fatalities from progressive multifocal leukoencephalopathy (PML), Harr noted the AE file documented 7 additional fatalities among Tysabri patients. One was attributed to pneumocystis pneumonia, another to herpes encephalitis, and four others to sepsis. The Tysabri AE file also documented "numerous" nonfatal infections.

Biogen, who markets the drug with Elan, has downplayed the significance of the data in the AE file. A Biogen spokesman said a Biogen/Elan analysis found no statistically significant differences in serious adverse events between Tysabri and a placebo in several clinical trials.

FDA has declined to comment.

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