By Brady Huggett

Eli Lilly and Co. received an ¿approvable¿ letter from the FDA for its sepsis product, Xigris, and now will begin working through the blockades to approval.

The FDA¿s Anti-Infective Drugs Advisory Committee officially deadlocked on the drug¿s efficacy and safety earlier this month, voting 10-to-10. Lilly is seeking approval for the treatment of severe sepsis ¿ sepsis with associated acute organ dysfunction. (See BioWorld Today, Oct. 17, 2001.)

¿We feel this is a good signal that approval will occur in the near term,¿ said Anne Griffin, spokeswoman for Indianapolis-based Lilly. ¿We continue to have discussions with the FDA to ensure we are providing it with the information that it needs.¿

Lilly must deal with issues over labeling, including the scope of the product¿s indication, post-approval trials and manufacturing, Griffin said.

There are no drugs on the market for sepsis, and the disease has baffled a number of companies that pursued various drug development strategies. The disease is caused by a bacterial infection and can spread in the blood. More than 215,000 people die annually in the U.S. from sepsis. (See BioWorld Today, April 30, 2001.)

The committee reviewing Xigris just weeks ago hinted that perhaps the drug would be best suited only for the most severe cases. The product, formerly called Zovant, is a genetically engineered version of the human activated protein C molecule. The molecule is designed to control the deadly effects of sepsis, including inflammation, coagulation and suppression of fibrinolysis.

Eli Lilly¿s next move is to follow the approval path laid out for Xigris.

¿We are very pleased with the outcome and feel we are one step closer to approval,¿ Griffin told BioWorld Today.

Eli Lilly¿s stock (NYSE:LLY) fell 33 cents Monday to close at $79.37.