Eli Lilly is withdrawing its septic shock treatment, Xigris®, from all markets. The decision was made after a study showed that the therapy did not reduce mortality in patients. The company is working with regulatory agencies on this withdrawal and is in the process of notifying healthcare 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," says Timothy Garnett, M.D., Lilly's svp and CMO. "Patients currently receiving treatment with Xigris should have treatment discontinued, and Xigris treatment should not be initiated for new patients."
As a result of the withdrawal, Lilly is revising its earnings per share guidance on a reported basis for full year 2011 from $3.89–$3.94, predicted on October 20, to $3.84–$3.89. BioCritica has sales and marketing rights for Xigris in the U.S. and Puerto Rico, and Lilly sells and markets Xigris in other countries.
Xigris was approved in the U.S. in November 2001 based on the results of the Prowess study and was licensed in the EU in 2002. Lilly committed to conducting a study as a condition for continued market authorization in Europe and in March of 2008 started the Prowess-Shock study.
It was designed as a placebo-controlled trial to help refine appropriate patient identification for treatment with Xigris and to confirm the benefit-risk profile of the product. The trial did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock.
"We believe the original Xigris approval was appropriate, and these recent results were quite unexpected," Garnett notes. "A contributing factor to these study results could be advances in the standard of care for treating severe sepsis over the past 10 years."
Xigris is a recombinant form of human activated protein C and is administered by intravenous infusion. FDA sanction covers Xigris for the reduction of mortality in adult patients with severe sepsis who have a high risk of death. EMA approval covers treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care.