Eli Lilly withdraws sepsis treatment Xigris

Lilly is working with regulatory agencies to withdraw Xigris and notify health care professionals and clinical trial investigators.

Eli Lilly and Company announced Tuesday the withdrawal of its Xigris product in all markets following results of the PROWESS-SHOCK study of patients suffering from septic shock, commonly known as sepsis, a complication after common illnesses such as pneumonia and bacterial infections.

According to a Lilly statement, the study "did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock."

Lilly is now working with regulatory agencies on this withdrawal, and is in the process of notifying health care professionals and clinical trial investigators.

"While there were no new safety findings, the study failed to demonstrate that Xigris improved patient survival and thus calls into question the benefit-risk profile of Xigris and its continued use," Dr. Timothy Garnett, Lilly's Senior Vice President and Chief Medical Officer, said in the company's statement. "Patients currently receiving treatment with Xigris should have treatment discontinued, and Xigris treatment should not be initiated for new patients."

Garnett added the results were unexpected.

Xigris was approved by the Food and Drug Administration in November 2001, and was licensed in Europe in 2002.

The PROWESS-SHOCK study began in March of 2008 as a condition for continued market authorization in Europe.

Patients, physicians, pharmacists, or other healthcare professionals with additional questions about Xigris should contact The Lilly Answer Center at 1-800-LillyRx or visit .