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Lilly sepsis drug gets nod
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November 21, 2001: 5:59 p.m. ET
FDA OKs Eli Lilly's Xigris for treatment of high-risk patients with sepsis.
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NEW YORK (CNN/Money) - The U.S. Food and Drug Administration on Wednesday approved Eli Lilly and Co.'s drug Xigris for treating sepsis, a blood condition brought on by severe infection which can cause organ failure.
Shares of Lilly (LLY: up $2.19 to $83.33, Research, Estimates) jumped more than 2 percent after the news was released. The company said it will launch Xigris within days.
About 215,000 people die of sepsis each year and the disease previously had no approved treatment.
"The approval of Xigris demonstrates the ability of government and industry to meet a pressing unmet medical need," said Sidney Taurel, Lilly chairman and CEO, in a statement. "The FDA should be commended for addressing a very complex medical condition expeditiously."
"Xigris is a new treatment that helps to save the lives of patients with the most severe forms of sepsis," said Bernard A. Schwetz, D.V.M., Ph.D., the FDA's acting principal deputy commissioner. "While not every one will benefit from this treatment, we believe the approval of Xigris is an important advance for the treatment of this often deadly disease."
Tim Anderson, drug analyst with Prudential Securities, said approval was a good, if expected, event for Lilly and is projecting sales of $480 million for the drug in 2002.
According to the FDA, Xigris was approved for treatment of adult patients with severe sepsis with an especially high risk of dying from the disease. In trials, the drug reduced mortality in higher-risk patients by 13 percent.
Anderson said the next development to watch is how pharmacies and insurance companies apply the labeling criteria of "severe" and "high risk" and how much of the sepsis population is prevented from using the drug.
Lilly said it is working with the FDA "to institute post-approval trials which will include a study of the efficacy of Xigris in adult patients with severe sepsis who have a lower risk of death and a study in pediatric patents with severe sepsis."
Anderson said the success of that push will be data-driven.
Lilly's hopes for the drug were dealt a blow in October, when the FDA advisory panel was split on whether or not to approve the drug. The FDA usually follows the advisory panel's recommendation.
But the company said it regained confidence when the FDA sent a letter outlining the requirements for approval, which included settling issues with the drug's labeling, post-approval clinical trials, and manufacturing inspections.
A setback for Chiron
Biotech company Chiron Corp., however, said Wednesday its treatment for severe sepsis, tifacogin, was ineffective in Phase 3 clinical trials.
Shares of Chiron (CHIR: down $4.50 to $45.59, Research, Estimates) plunged nearly 9 percent in regular trading on the Nasdaq.
"We have always recognized the challenges of developing a therapeutic for severe sepsis," said Sean Lance, Chiron chairman and CEO, in a statement. "We will be undertaking a full review of the data from the Phase 3 trial, and we will make future development decision about tifacogin after we have completed the analysis of the data." 
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