October 17, 2001 WASHINGTON (AP) - Government scientists split Tuesday on whether a long-anticipated drug to treat deadly sepsis works well enough to sell.
Some advisers to the Food and Drug Administration said Eli Lilly's Xigris appeared to fight the bloodstream infections, while others argued that it's impossible to tell how well the drug worked because the sickest patients were excluded from study.
Sepsis strikes about 750,000 Americans a year, at least 225,000 of whom die when the infection leads to complications that destroy their organs. Many illnesses can lead to sepsis, including trauma, surgical complications and pneumonia.
Patients are treated with antibiotics, fluids and other supportive care, but there is no drug that directly attacks the way sepsis destroys organs - by causing blood inflammation and clotting.
Lilly's drug is a biologically engineered form of a natural blood product - called activated protein C - that curbs those very problems.
Lilly-funded researchers studied 1,690 patients with severe sepsis, giving half the intravenous drug, trade-named Xigris, and half a placebo for 28 days.
The FDA analyzed the data and concluded that Xigris caused a 6 percent reduction in mortality. But some of the FDA's independent advisers questioned just who benefitted, because some of the sickest patients were excluded, explained FDA medical officer Dr. Karen Weiss.
Xigris also can occasionally cause severe bleeding, which led to four deaths in the study, the FDA said.
Faced with split advice, FDA doctors will talk with Lilly researchers. "We just have to take a lot of things into consideration," Weiss said.
Shares of Lilly were up 94 cents to close at $79 in trading on the New York Stock Exchange, but fell $5, or 6.3 percent, in extended trading.
Copyright 2001 The Associated Press. All rights reserved.
