Eli Lilly, a global pharmaceutical company, pulled its drug, Xigris, from the market after clinical trials showed it provided no benefit for patients in septic shock.
Although it only affects about 1 to 2 percent of hospitalized patients in the U.S., sepsis is a life threatening illness. It is caused when a person's immune system aggressively responds to infections. Inflammatory proteins are released into the body, which can cause shock and shut down vital organs.
From the start, some researchers questioned the efficacy of this drug. Lilly had claimed the drug was safe and ready for use, but some studies found that the intravenous drug had actually increased the risk of serious bleeding in patients. Still, the Food and Drug Administration approved the drug in 2001, after a 28 day showed some positive results. However, half the members of the FDA advisory panel voted against Xigris.
The Food and Drug Administration approved the drug in 2001 after a single, small trial showed a 28-day survival benefit.
In 2007, the European regulartory advisory panel had concluded that initial positive test results about Xigris were not reproduced. They then asked Lilly to conduct a new study to test the efficacy of the drug. In March 2008, Lilly began a new study. However, after a 1,680-patient study, Lilly found there was no statistically significant reduction in deaths compared to the patients who only received a placebo, according to the Dow Jones Newswires.
While there were no new safety findings, the study failed to demonstrate that Xigris improved patient survival and thus calls into question the benefit-risk profile of Xigris and its continued use, said Timothy Garnett, Lilly's chief medical officer, in a statement.
Lilly warned that patients currently taking the drug should immediately stop and doctors should not even consider prescribing their new patients with Xigris.
The drug received endorsements from 11 professional societies after launching a Surviving Sepsis campaign. Doctors who served on the guideline panels for those professional societies earned consulting fees. This raises new questions about the ethical standards of those doctors as well as the ethics of Eli Lilly's campaign.
Xigris was projected become a blockbuster drug that made billions for the company. So far, it has garnered about $1.5 billion after being approved in the U.S. States and Europe the following year. Last year alone the drug made about $104 million and $74 million in the first nine months of 2011.
Lilly's shares fell about 47 cents or 1.2 percent in recent trading.