New Therapy Reduces Mortality in Sepsis Patients

The drug, drotrecogin alfa (Xigris), has been cleared by the U.S. Food and Drug Administration (FDA) for use in adult patients with severe sepsis who have a high risk of death. Severe sepsis is associated with acute organ dysfunction.

A large international phase III clinical trial (PROWESS) involving 1,690 patients with severe sepsis showed mortality rates of 25% among patients taking drotrecogin alfa versus 31% for patients treated with placebo. Bleeding was the most common adverse reaction associated with drotrecogin alfa therapy. The drug, a recombinant form of human activated protein C (APC), is administered by intravenous infusion.

Sepsis takes the lives of more than 200,000 people in the United States alone each year. It is the leading cause of death in noncoronary intensive care units (ICUs). Current therapies include treatment for the infection and supportive care such as mechanical ventilation and kidney dialysis. Drotrecogin is the product of Eli Lilly and Company (Indianapolis, IN, USA). The company plans to conduct a study of the efficacy of the drug in adult patients with severe sepsis who have a lower risk of death and also a study in pediatric sepsis patients.

"The approval of Xigris breaks new ground,” says Mitchell Levy, M.D., associate professor of medicine at Brown University School of Medicine (Providence, RI, USA). "For decades, physicians have been awaiting the development of a product such as Xigris to treat patients at high risk of death from severe sepsis.”




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