WASHINGTON — The government approved a drug Wednesday 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.
Overall, the drug reduced mortality by 6 percent. But the FDA looked more closely at how ill each patient was, and found that Xigris lowered mortality by 13 percent in those who initially had been deemed at highest risk of death. In lower-risk patients, the drug seemed to make no difference.
Who is a high-risk sepsis patient? Among the criteria are patients with underlying chronic illnesses before sepsis struck; those in intensive care, on ventilators or whose blood pressure shows a severe response to sepsis; and older patients.
Because Xigris works by interfering with blood clotting, it can cause severe bleeding, including strokes, the FDA warned. In clinical trials, serious bleeding occurred in 2.4 percent of patients.
No one yet knows if Xigris will help children with sepsis, the FDA cautioned. Lilly agreed to FDA requests to study Xigris in children, and to further low-risk adult sepsis patients to tease out whether it really makes a difference for them.
Each patient’s weight and extent of disease determine the dose, but a typical treatment will cost about $6,800, a Lilly spokesman said.
Copyright ©2001 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.