Pharmaceutical company Eli Lilly has announced the withdrawal of its severe sepsis drug activated protein C, or drotrecogin alfa (proprietary name Xigris). This is because the PROWESS-SHOCK study, now complete, showed no benefit in its primary endpoint of 28 day mortality when compared with placebo in septic shock patients. There was also no benefit in a subgroup of patients with protein C deficiency, and no significant increased risk of severe bleeding.
The European Medicines Agency’s Instructions are:
At this stage physicians should not initiate treatment with Xigris in new patients and should stop ongoing treatment
The US Food and Drug Administration’s Instructions are:
Xigris treatment should not be started in new patients. Xigris treatment should be stopped in patients being treated with Xigris.
All remaining Xigris product should be returned to the supplier from whom it was purchased.
The UK Intensive Care Society’s Announcement contains a link to Eli Lilly’s press release.