Thursday, November 22, 2001

The government approved a drug yesterday that could save tens of thousands of lives a year from sepsis the first treatment to directly attack these overwhelming bloodstream infections.
Doctors call Xigris a breakthrough, and Eli Lilly & Co. pledged to ship the medicine to hospital intensive-care units within days.
“Sepsis is a huge public health problem,” said Dr. Gordon Bernard, who led clinical trials of the medication. “This drug, although not a cure-all it doesn’t save everyone it reduces the mortality, and it’s the only drug ever shown to do that.”
The Food and Drug Administration approved Xigris as a treatment for the most severe sepsis patients, those deemed least likely to survive. When given to such people, the drug can cut the chances of death by 13 percent. “We’re talking about tens of thousands of lives per year potentially saved by this product if used appropriately,” said Dr. Jay Siegel, FDA’s director of blood therapies.
Sepsis is a bacterial infection of the bloodstream that strikes about 750,000 Americans a year. Some 225,000 of them die when the infection sets off a chain of chemical reactions that destroy their organs.
Sepsis can strike anyone it can be a complication of trauma, surgery, pneumonia and numerous other illnesses. Patients are treated with antibiotics, fluids, ventilators for lung failure, and other supportive care.
But until now, there has been no drug that directly attacks the way sepsis destroys organs by causing inflammation and blood clots. After a decade of failure by numerous drug companies to find such a targeted therapy, Eli Lilly came up with an answer: a biologically engineered form of a natural blood product activated protein C that curbs blood clotting and, to a lesser degree, inflammation.

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