Eli Lilly Gets FDA Approval for First Sepsis Drug BYKIM DIXON
WASHINGTON — Eli Lilly & Co. won Food and Drug Administration approval of its Xigris drug for severe sepsis, the first treatment approved for the often fatal overreaction to infection.
Analysts estimate annual sales for Xigris, a genetically engineered protein, will top $1 billion within a few years of its introduction. Lilly needs new products to make up for declining sales of its Prozac antidepressant, which lost U.S. patent protection in August.
Lilly succeeded in developing a treatment for sepsis after more than half a dozen other drug makers have failed in the last decade. Also Wednesday, Chiron Corp. said its experimental sepsis drug failed to reduce deaths in a key study. Approval of Xigris will raise confidence about other Lilly drugs, analysts said.
“It means that Lilly has some good people, not just scientists coming up with the drugs, but the regulatory folks shepherding them through what has been a treacherous FDA [process],” said John Farrall, an analyst with National City Private Investment Advisors, which holds Lilly shares.
Lilly shares rose $2.19 to close at $83.33 on the New York Stock Exchange. They have fallen 10% this year, in line with the decline in the AMEX pharmaceutical index.
Chiron shares fell $4.50, or 9%, to close at $45.59 on Nasdaq, after the Emeryville, Calif.-based company said a final-stage trial of its tifacogin drug for treating severe sepsis didn’t meet its main goal of reducing deaths.
Lilly’s Xigris won approval to treat adults with an “especially high risk of dying from sepsis,” the FDA said. Lilly said it will charge about $6,800 a patient for the drug, which is administered over four days.
Agency reviewers had expressed concerns about the drug, including its potential to cause excessive bleeding, its most serious side effect.
About 750,000 people are diagnosed with sepsis annually and about one-third of those patients die from the condition, the FDA said. Many of these cases occur in people with cancer or other advanced terminal illnesses, making it difficult to estimate how many patients are good candidates for the Lilly drug, doctors and analysts have said.
In sepsis, the body’s immune system overreacts to infection, setting off a series of reactions, including dangerous blood clotting in smaller vessels. That can lead to organ failure. The complicated cascade of reactions has made it difficult for drug makers to pinpoint a target that can halt the reactions or prevent them from starting.
Before Chiron, Aventis, Xoma Ltd., Centocor Inc. and other companies made unsuccessful attempts to develop a sepsis treatment. Other late-stage clinical trial failures include Cortech Inc.’s Bradycor and Synergen Inc.’s Antril.
Tifacogin is Chiron’s second failure in the development of a sepsis drug. In 1994, Chiron abandoned testing of its T-88 compound.
