November 2011

On 25 October 2011, Eli Lilly and Company announced the withdrawal of its Xigris (drotrecogin alfa [activated]) product in all markets following results of the PROWESS–SHOCK study, which showed the study did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock. The company is working with regulatory agencies on this withdrawal, and is in the process of notifying healthcare professionals and clinical trial investigators.

As a result of this, NICE has withdrawn its guidance on the use of drotrecogin alfa (activated) for severe sepsis.