Drotrecogin alfa (activated): the first FDA-approved treatment for severe sepsis

Anita Marie Hosac, PharmD

From the Department of Pharmacy Services, Baylor University Medical Center, Dallas, Texas.

Corresponding author: Anita Marie Hosac, PharmD, Department of Pharmacy Services, Baylor University Medical Center, 3500 Gaston Avenue, Dallas, Texas 75246 (e-mail: anith@baylorhealth.edu).

Drotrecogin alfa (activated) (Xigris, Eli Lilly and Company, Indianapolis, Ind) is a recombinant form of human activated protein C. It was approved by the Food and Drug Administration in the last quarter of 2001 for the reduction of mortality due to severe sepsis in adult patients who are at high risk of death (1). This is a unique indication. While many investigational drugs have been proposed as treatments for sepsis in the past, and several have even made it to clinical trials (2), only drotrecogin alfa (activated) has shown a survival benefit. (BUMC Proceedings 2002;15:224-227)