Withdrawn Sepsis Drug Vindicated

A new study suggests that a drug for blood poisoning that was withdrawn by its manufacturer does work after all.

By | July 17, 2012

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Drotrecogin alfa (activated), a serine protease with anti-inflammatory and anti-thrombotic properties was approved in 2001 in the United States for use against severe sepsis in adults with multiple organ failures—then withdrawn from the market 10 years later after a study disproved its claims of efficacy. But new evidence suggests that it may actually help reduce the risk of death in sepsis patients, a new study published yesterday (July 16) in The Lancet Infectious Diseases found.

Manufactured and marketed as Xigris by Eli Lilly, drotrecogin alfa (activated) was initially approved for use in Europe and the United States after randomized, double-blind, placebo-controlled clinical trials showed it reduced the mortality rate in severe sepsis patients by about 20 percent. However, in 2008, after several studies failed to produce similar results, Eli Lilly agreed to conduct a new study into the efficacy of Xigris. The results prompted the company to voluntarily withdraw the drug from the market in October 2011.

In the new Lancet study, which followed real-life usage of the drug over the decade it was out on the market, researchers reported that use of Xigris indeed reduced the risk of death by 18 percent.

“Although these data might not represent the highest levels of evidence, many of us (including me) maintain that we can learn a lot from such real-life studies,” Jean-Louis Vincent, Professor of Intensive Care at the Université Libre de Bruxelles who wrote an accompanying commentary on the new study, said in a press release. “The death rate from sepsis is unacceptable and new drugs are needed urgently, so one might ask whether drotrecogin alfa (activated) can be resurrected.  However, unfortunately Eli Lilly has given up and the drug cannot be produced easily.”

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Avatar of: FDAmatters


Posts: 3

July 17, 2012

My understanding was that the efficacy of the drug was not the issue in its withdrawal. It worked in 2001 and it still works. HOWEVER, the standard of sepsis care in 2001 was very low, so the product's efficacy produced a positive risk/benefit. By 2008, the standard of sepsis care had risen sufficiently that the risk/benefit advantage of using the drug was no longer sufficient to justify its use. 

If so, then re-discovering that patients benefited in 2001 is no great revelation, nor does that finding undercut the decision that was made after the 2008 studies. n

Avatar of: Joan


Posts: 1457

July 18, 2012

There is a device developed by CTSO that has been shown to calm the cytokine storm in sepsis patients. It is being used in Germany now. 

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