In Sepsis, Having the Right Drug Still May Not Be Enough

In conjunction with the initial sales numbers for its sepsis drug, Xigris, manufacturer Eli Lilly cautioned that "the selection of patients with severe sepsis as indicated on the label has been complex for physicians initially." To address the knowledge gap, the National Institutes of Health has awarded a $6 million grant for a study of risk factors for sepsis, the first study of its kind and the biggest single R1 grant ever funded through NIH's National Institute of General Medical Sciences. The Xigris pivotal trial was the only one of 31 Phase III trials of sepsis drugs that didn't fail. "It's not just understanding how the drug works, it's believing in it," says the principal investigator for the NIH study, which should help move the process forward.

Eli Lilly & Co. 's update on early sales of its sepsis drug, Xigris (drotrecogin alfa, or activated protein C) serves as a reminder that even with a new drug finally in hand to treat this often rapidly fatal disease, the inability to diagnose sepsis early remains a significant clinical challenge.

Since Xigris's launch in late November, sales have reached $35 million—$14 million of it coming in the first two months...

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