FDA releases Xigris data; postpones meeting

FDA released its evaluation of Eli Lilly's Xigris drotrecogin alfa on Tuesday, concluding that it is effective in the treatment of sepsis. Because of the national security emergency, the agency has postponed Wednesday's meeting of the Anti-Infective Advisory Committee to review the product. A new date has not been announced.

Xigris, a recombinant human activated protein C, prevents clot formation, breaks up existing clots and reduces inflammation in blood vessels. In a pivotal study in adults with severe sepsis, there was a 25% mortality rate at 28 days among treated patients compared to 31% mortality among those who received placebo. The 6% difference was statistically significant (when results were stratified according to a number of baseline characteristics the p-value was 0.0054; the non-stratified p-value was 0.0049). ...