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Xigris Withdrawn After Study Finds No Improvement in Survival

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Sepsis drug Xigris (Drotrecogin alfa) has been withdrawn from the market by drug maker, Eli Lilly and Company; this, following poor outcomes in a recent clinical trial. According to Reuters, Xigris did not improve survival in the PROWESS-SHOCK trial. NewsInferno previously wrote that Eli Lilly’s intravenous sepsis treatment was the subject of a U.S. Food and Drug Administration (FDA) safety review prompted by a prior study that revealed Xigris increased risks for dangerous internal bleeding when used by patients with a recent hemorrhage history. Similar to a natural protein produced in the body, Xigris decreases inflammation and blood clot formation in blood vessels and increases blood clot breakdown. Sepsis, which takes place in one-to-two percent of all U.S. hospitalizations, is typically severe and often life-threatening and is caused by the immune system’s hyper-aggressive response to infections, explained Reuters. When in sepsis, the body releases inflammatory proteins that lead to shock and multiple organ shutdown. NewsInferno described sepsis—blood poisoning—as a whole-body inflammatory state known as systemic inflammatory response syndrome (SIRS) that can develop as a complication following common illnesses, including pneumonia and bacterial infections. Sepsis causes approximately 1400 daily deaths worldwide, said NewsInferno. Although Xigris did see global sales of $100 million last year—$1.5 billion since its 2001 U.S. and 2002 European approvals—it never met sales projections, noted Reuters. “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,” Timothy Garnett, Lilly’s chief medical officer, said in a statement yesterday, Reuters reported. According to Lilly, patients currently being treated with Xigris should stop the medication and physicians should not start new patients on the now-banned drug, wrote Reuters. The failed PROWESS-SHOCK study was initiated in March 2008 as a condition for the drug’s continued market authorization in Europe, noted Reuters. The 1,696-patient study revealed that Xigris never met the study’s key goal for a statistically significant death reduction from any cause over a 28-day period in septic shock

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patients, said Reuters. As a matter-of-fact, the European Medicines Agency (EMA) found that 26.4% of Xigris patients died versus 24.2% percent of placebo patients; a difference not considered to be statistically significant. Severe bleeding events during the study were similar, “suggesting there was no increased harm” from the Lilly drug, said the EMA, wrote Reuters. Because of intensive care unit improvements, said Lilly’s Garnett, “the incremental benefit of Xigris is no longer apparent, and no longer clinically relevant,” Reuters reported.

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