Xigris licence withdrawn

30 November 2011

Xigris was indicated for the treatment of severe sepsis with multiple organ failure | SCIENCE PHOTO LIBRARY

Xigris (activated drotrecogin alfa) has been withdrawn by Lilly after it failed to show a survival benefit in a clinical trial in patients with septic shock.

Results from the PROWESS-SHOCK study showed the overall 28-day mortality was 26.4% in drotrecogin-alfa-treated patients (n=846) compared with 24.2% in patients given placebo (n=834; p=0.31). No new safety findings were observed.

Drotrecogin alfa must not be initiated in new patients and should be discontinued in patients currently receiving treatment.

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