Where now for Xigris?

Todd Fraser on 26-10-2011

The big news this week is the fall from grace for the sepsis drug, Xigris. It is fair to say that much of the air had already leaked from Activated Protein C balloon, but confirmation this week that it is to be withdrawn from sale puts a full stop on the story. The manufacturer has hooked its star product after years of speculation on the back of the failure of the drug to reduce 28 day mortality in sepsis, the primary outcome in the PROWESS-SHOCK study. It is a spectacular decline from its equally spectacular entrance into clinical practice on the back of the now infamous PROWESS study. Like so many "magic bullet" before, Xigris has come and gone, and the conclusion must be obvious : can one drug really impact on such a complex interactive system like inflammation?

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Todd Fraser wrote 10-26-2011 03:47:35 pm
A link to the Reuter's report :

http://www.reuters.com/article/2011/10/25/elililly-idUSN1E79O08320111025

Alex McKenzie wrote 10-26-2011 03:53:23 pm
Wa wa wa waaaaaaaah!

Its not like we didn't see that coming.

The response from Lily is hilarious - Xigris doesn't show any benefit because we're better at saving people from sepsis now!

Jo Butler wrote 11-03-2011 09:08:40 am
What's most surprising is that it took this long - I've personally not used it for 6 years.

In reality the evidence was pretty weak, and the only large scale trial to support it had serious problems with it. Rinaldo Bellomo reviewed this at the (then) JFICM ASM a few years ago and it was pretty convincing. Problems such as the cell line producing the drug changing mid study, and the apparent efficacy changing with it. Centres were dropped and others added. Those excluded were APC under performers, and in those included, APC seemed to do well. And so on.

James O'Connor wrote 11-03-2011 09:09:55 am
Rinaldo can convince you of just about anything though...