FDA May OK Lilly's Sepsis Drug

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Monday October 29 11:01 AM ET

FDA May OK Lilly's Sepsis Drug

NEW YORK (AP) - Eli Lilly and Co. said Monday it received an

approvable letter from the U.S. Food and Drug Administration (news -

web sites) for its sepsis drug Xigris and that it hopes to launch the

product by the end of the year.

Final approval of the drug, which would be the only sepsis treatment,

is contingent upon several factors including negotiations over the

language on the label, agreement on post-approval clinical trials and

successful completion of manufacturing inspections.

Approval of the drug was unexpectedly thrown into question earlier

this month when an FDA panel of 20 scientists was evenly divided over

whether to recommend it be sold. Most analysts had been expecting the

drug to sail through the FDA panel and were touting it as a

blockbuster that would replace some of the revenues lost when Lilly's

blockbuster anti-depressant Prozac lost its patent over the summer.

Sepsis is an infection that kills about 225,000 Americans a year.

``We are very pleased about the outcome given how close the committee

decision was,'' said Lilly spokesman Dan . ``We are still

targeting launch by the end of the year.''

On Monday morning, Lilly's shares rose $1.61, or 2 percent, to $81.31

on the New York Stock Exchange.