Xigris drotrecogin alfa: Development discontinued

Eli Lilly withdrew Xigris from the global market after data from the double-blind, international Phase III PROWESS-SHOCK trial in 1,696 patients showed that the sepsis drug missed the primary endpoint of significantly reducing the 28-day all-cause mortality rate vs. placebo (26.4% vs. 24.2%, p=0.31). Xigris also missed the secondary endpoint of significantly reducing mortality in a subgroup of patients with severe protein C deficiency. The risk of severe bleeding events was similar between treatment groups (1.2% vs. 1%). Based on the results, the pharma has also decided to discontinue all clinical trials of Xigris. Lilly said it is working with regulatory agencies on the withdrawal and is in the process of notifying health care professionals and clinical trial investigators. The pharma added that advances in standard of care for treating severe sepsis over the past 10 years could be a contributing factor to the results, but did not disclose details.

In 2001, FDA approved Xigris to treat adult patients with severe sepsis who have a high risk of death, while EMA approved the drug in 2002 to treat adult patients with severe sepsis with multiple organ failure when added to best standard care. The PROWESS-SHOCK trial was initiated in March 2008 as a condition for continued marketing authorization in Europe. BioCritica, which was formed in May by Lilly and investors Care Capital and NovaQuest, has exclusive U.S. rights to develop and commercialize Xigris, while Lilly has rights elsewhere (see BioCentury, May 30). BioCritica characterized the results as a "huge disappointment" and said it has not yet determined plans for the future of the company. ...