A Phase 3 clinical trial assessing the effect of Drotrecogin, a recombinant human activated protein C–Xigris® in managing sepsis.
Xigris also has anti-thrombotic, anti-inflammatory, and profibrinolytic properties.
Conclusion It worked; FDA approved (2002); Lilly’s stock soared; the villagers rejoiced.
Eli Lilly had hoped it would become a blockbuster drug with annual sales of $1bn, given that sepsis kills 200,000 Americans/year; sales were tepid (circa $200 million/annually).
PROWESS was followed by the European PROWESS-SHOCK trial which reported in 2011 that there was no gain in 28-day survival of septic shock patients. Xigris was later withdrawn from the market.
Formal name Recombinant Human Activated Protein C [Zovant™] Worldwide Evaluation in Severe Sepsis