FDA delays review of Lilly's sepsis drug

The US Food and Drug Administration has unexpectedly delayed its reviewof Eli Lilly's sepsis treatment Xigris (drotrecogin alfa; formerly Zovant) from July 27 to October 27. The company has not given a reason as to why this decision was made, but said it did not think that the agency had concerns about the research submitted with the application.

Recently, Lilly's Xigris had been granted fast-track review by the FDA due to the lack of effective drugs on the market for the treatment of sepsis, and the company was expecting US approval and launch early in the third quarter of this year (Marketletter April 9). The FDA has assured Lilly that its marketing application for Xigris remains under priority review, and the company still hopes to launch the product this year, depending on an agency inspection of the Catalytica unit of the Dutch company DSM, which makes Lilly's finished products. Lilly noted that the inspection will not take place until Catalytica resolves unrelated issues raised in a warning letter from the FDA.

Xigris is expected to generate annual sales of more than $2 billion, according to analyst Len Yaffe at Banc of America Securities. Lilly needs to launch a billion-dollar drug in order to replace the revenue that will be lost when its antidepressant Prozac (fluoxetine), which has annual sales of $2.5 billion, loses its market exclusivity later this year (Marketletter August 25, 2000), and will face strong generic competition from companies such as Pharmaceutical Resources, Merck & Co and Bar Laboratories. Lilly's share fell $2.80 to $83.70 following the news on June 13.