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FOR IMMEDIATE RELEASE
Wednesday, Nov. 21, 2001
Contact: HHS Press Office
(202) 690-6343

STATEMENT BY
HHS SECRETARY TOMMY G. THOMPSON
Regarding FDA Approval of New Drug to Treat Sepsis


Today's action by the Food and Drug Administration to approve a new biologic product for treatment of severe sepsis is a hopeful and significant step, because it has been shown to be life-saving.

Sepsis occurs when the body reacts to a serious infection, producing a response that can lead to organ failure, loss of limbs, and in almost a third of cases, loss of life. Medical science has long sought an effective treatment for sepsis, but until now, doctors have been limited to providing supportive care while treating the underlying infection. These measures all too often fail to prevent the devastating consequences of the disease.

Today's approval of the new weapon against sepsis called Xigris is a hopeful milestone because this product is designed to actually interrupt the body's harmful responses to severe infection. It is indicated for adults with severe sepsis who have an especially high risk of death. As the first approved treatment for this life-threatening disease, the arrival of this product is a promising development.

I congratulate the researchers whose long efforts have yielded Xigris, and I commend the FDA for its careful work in reviewing and monitoring this new product.

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