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Lilly nears Xigris approval
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October 29, 2001: 10:10 a.m. ET
The FDA sends an 'approval letter' about Eli Lilly's sepsis drug.
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NEW YORK (CNNmoney) - Drugmaker Eli Lilly & Co. said Monday it drew a step nearer to approval of its sepsis drug Xigris when the U.S. Food and Drug Administration outlined in a letter the issues it wanted addressed before it would approve the drug.
Sepsis, a condition that can lead to organ failure, kills 215,000 people each year, Lilly said, and has no approved treatment.
The FDA, in an 'approval letter,' said final approval of Xigris depends on settling issues with the drug's labeling, post-approval clinical trials and manufacturing inspections, according to a Lilly statement.
"The action by the FDA puts us one step closer to the approval of Xigris, which we believe will occur in the near term," said Dr. John Lechleiter, Lilly's executive vice president of pharmaceutical products and corporate development.
Lilly stock has been under pressure for months as the FDA has delayed approval of the drug.
Earlier this month, an FDA advisory panel was split in its opinion about whether or not to approve the drug, citing concerns with its side effects -- including four deaths in clinical trials.
Indianapolis-based Lilly has also suffered the ill effects of court approval of generic forms of its antidepressant drug Prozac.
Lilly (LLY: up $1.05 to $80.75, Research, Estimates) shares rose in early trading. 
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