FDA May OK Lilly's Sepsis Drug
Monday, October 29th 2001, 12:00 am
By: News On 6
NEW YORK (AP) _ Eli Lilly and Co. said Monday it received an approvable letter from the U.S. Food and Drug Administration 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 Collins. ``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.