Xigris withdrawal
October 26, 2011
ELI Lilly has issued an immediate
withdrawal of its Xigris(R)
[drotrecogin alfa (activated)]
product in all markets.
Xigris is a recombinant form of
human Activated Protein C and is
used as an anticoagulant, antiinflammatory
with fibrinolytic
properties.
It’s approved in Australia, the US,
Canada and the EU for the
reduction of mortality in adult
patients with severe sepsis, but a
recent study found the drug did
not provide a significant reduction
in 28-day mortality in patients with
septic shock.
Eli Lilly chief medical officer,
Timothy Garnett, said the findings
call into question the risk-benefit
profile of the drug, but defended
its original approval saying the
unexpected results could be due to
advances in sepsis treatment over
the last decade.
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