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FDA delays Lilly drug
June 13, 2001: 10:19 a.m. ET

Agency extends review of sepsis treatment; Lilly stock falls in early trade
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NEW YORK (CNNfn) - U.S. regulators will take more time to review a new sepsis treatment from Eli Lilly and Co., the drugmaker said Wednesday, news that put its stock under pressure.

The Food and Drug Administration extended its review date to Oct. 27 from July 27 on Lilly's application for a new treatment for sepsis, a condition that can lead to organ failure and death as a result of an infection. The condition has no approved treatment.

Though Lilly (LLY: down $2.98 to $83.52, Research, Estimates) said it doubted the FDA is concerned about the drug's approvability, the company's stock plunged nearly 4 percent in morning trading on the New York Stock Exchange.

Lilly said the FDA has assured it that the application remains under priority review and that the review process will be completed as soon as possible.

Based on current information, Lilly said, it still plans to launch the treatment, drotrecogin alfa (activated), in the U.S. in the second half of the year. It will be sold under the brand name Xigris.

Indianapolis-based Lilly also reconfirmed its previously announced earnings-per-share forecast for the second quarter of 73 to 75 cents and for the full year 2001 of $2.75 to $2.85, excluding any unusual items and assuming its blockbuster antidepressant Prozac will face general competition in the U.S. in August.

A U.S. appeals court recently upheld a ruling allowing the marketing of generic Prozac. Prozac sales had helped place Lilly among the top 10 U.S. drugmakers. graphic

-- from staff and wire reports


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Eli Lilly

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