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12:00 AM
Sep 30, 2002
 |  BioCentury  |  Product Development

Debate over Xigris

After a bumpy approval nearly a year ago, Eli Lilly and Co.'s Xigris drotrecogin alfa became the only sepsis compound to ever gain FDA approval. However, adoption by physicans has been slow, and editorials in last week's New England Journal of Medicine have reignited the debate over many contentious issues first visited during the compound's FDA committee review, including concerns over its side effect profile, characterization and uncertainty regarding how midstream protocol changes affected outcomes in the company's Phase III trials.

According to NEJM author Shaw Warren, associate professor of pediatrics at Harvard University, and colleagues at the NIH and University of Texas Southwestern Medical Center, changes in the protocol of the Phase III PROWESS trial make it difficult to extrapolate the data to clinical practice. These changes included patient inclusion/exclusion criteria, evidence of a higher risk of hemorrhage in Xigris-treated...

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