Drotrecogin alfa (activated) is recommended for adult patients who
- have severe sepsis that has resulted in multiple organ failure (two or more major organs are not working properly) and
- are being given the most appropriate intensive care support for their condition.
The use of drotrecogin alfa (activated) should be started and supervised by a specialist consultant with skills in intensive care and experience in the care of patients with sepsis.
Drotrecogin alpha (activated) for severe sepsis: withdrawal of product following recent clinical trial results
On 25 October 2011, Eli Lilly and Company announced the withdrawal of its Xigris(R) [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 health care professionals and clinical trial investigators.
As a result of this, NICE has withdrawn its guidance on the use of drotrecogin alpha (activated) for severe sepsis.