Xigris is withdrawn from all markets for Septic Shock

Xigris(drotrecogin alfa (activated)) from Eli Lilly ,which was first approved in the USA in 2001 and in the EU in 2002, is now withdrawn in all markets following results of the PROWESS-SHOCK study, which showed the drug did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock. While there were no new safety findings, the study failed to demonstrate that Xigris improved patient survival and thus calls into question the benefit-risk profile of Xigris and its continued use. Patients currently receiving treatment with Xigris should have treatment discontinued, and Xigris treatment should not be initiated for new patients.The PROWESS-SHOCK study was initiated in March of 2008 as a condition for continued market authorization in Europe. Lilly was committed to conduct a new placebo-controlled clinical trial to help refine appropriate patient identification for treatment with Xigris and to confirm the benefit-risk profile of the product. Xigris is sold in the USA and Puerto Rico via Lilly subsidiary, BioCritica Inc. and by Eli Lily in the rest of the world.