Eli Lilly and Company announced that Xigris (drotrecogin alfa [activated]) - the first life-saving therapy indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care - is now available in many countries in the European Union. The European launch comes less than two months after the European Commission granted Marketing Authorisation for Xigris in all 15-member states on Aug. 26, 2002. Since the U.S. approval in November 2001, Xigris has now been approved in over 30 countries.

"I have personally seen the devastation this condition can cause for patients and their families. We need all the weapons in our arsenal in order to combat this devastating condition. Now that Xigris is available in Europe, we will have that option," said Professor Jean-Louis Vincent, head of the department of intensive care at Erasme Hospital, University of Brussels.

"Lilly is once again proud to be leading the way in the production of an innovative treatment to improve patient care and help save lives. We are delighted to make Xigris available in Europe," said Richard Pilnik, president of European operations for Lilly.

The European Commission based its approval on the results of an international Phase III clinical trial known as PROWESS (Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis). Xigris reduced the relative risk of death from severe sepsis by nearly 20 per cent in the trial involving 1,690 patients who had sepsis with at least one associated organ dysfunction.

Severe sepsis is a complex syndrome that affects 1.6 million people worldwide and is associated with the loss of up to 135,0002 lives in European intensive care units every year - as many as lung cancer, breast cancer or colon cancer.3
Severe sepsis occurs when an infection (bacterial, viral, fungal or parasitic) - often the result of surgery, burns, cancer or major injury such as those sustained in a traffic accident - triggers a cascade of immune system responses that can lead to acute organ dysfunction and often death.

Xigris is a genetically engineered version of the human Activated Protein C molecule, a naturally occurring protein in the body that helps to balance many of the major forces behind sepsis, including coagulation (blood-clotting) and suppression of fibrinolysis (the body's clot-busting system). Additionally, patients with severe sepsis treated with Xigris had a more rapid decline in interleukin-6 levels, a global marker of inflammation, consistent with a reduction in the inflammatory response. The drug is administered to patients as a one-time, 96-hour infusion within an ICU setting. The precise dosage depends on the weight of the patient. In the EU, Xigris is approved for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care.

Safety and efficacy have not been established in pediatric patients with severe sepsis. In addition to the ADDRESS (Administration of Drotrecogin alfa [activated] in Early Severe Sepsis) trial investigating the use of Xigris in lower-risk patients, Lilly is undertaking trials of Xigris in children with severe sepsis, and investigating the concomitant use of low-dose heparin with Xigris.