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drotrecogin alfa [activated] (Xigris®)

Withdrawn

On 25 October, 2011, Eli Lilly and Company announced worldwide withdrawal of its Xigris® [drotrecogin alfa (activated)] product for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care.

The worldwide withdrawal (including the UK) has been announced following results of a clinical study (the PROWESS-SHOCK study), which showed that Xigris did not achieve a statistically significant reduction in 28-day all-cause mortality in patients with septic shock. The company is working in collaboration with regulatory agencies on the withdrawal, and is in the process of notifying health care professionals and clinical trial investigators.

Find out more about Lilly's withdrawal of this medicine. 

 

Drug Details

Drug Name: drotrecogin alfa [activated] (Xigris®)
SMC Drug ID: 13/02
Manufacturer: Eli Lilly and Company Ltd
Indication: Severe sepsis with multiple organ failure.
BNF Category:
Sub Category: 2.11 Antifibrinolytic drugs and haemostatics
Submission Type: Full submission
Status: Withdrawn
Date Advice Published: 4 October 2002

Extra Notes

On 25 October 2011, Eli Lilly and Company announced worldwide withdrawal of its Xigris® [drotrecogin alfa (activated)] product for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. www.lilly.co.uk/our-medicines/Xigris.pdf/++atfield++file

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