Lilly Announces Withdrawal of Xigris Following Recent Clinical Trial Results

27-Oct-2011 - USA
Eli Lilly and Company announced withdrawal of its Xigris® [drotrecogin alfa (activated)] product in all markets following results of the PROWESS-SHOCK study, which showed the study did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock. The company is 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," said Timothy Garnett, M.D., Lilly's Senior Vice President and Chief Medical Officer. "Patients currently receiving treatment with Xigris should have treatment discontinued, and Xigris treatment should not be initiated for new patients."
"We believe the original Xigris approval was appropriate and these recent results were quite unexpected," Garnett added. "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 was approved in the United States by the Food and Drug Administration (FDA) in November 2001, and was licensed in the European Union in 2002. The PROWESS-SHOCK study was initiated in March of 2008 as a condition for continued market authorization in Europe. Lilly committed to conduct a new placebo-controlled clinical trial to help refine appropriate patient identification for treatment with Xigris and to confirm the benefit-risk profile of the product.
BioCritica, Inc. has sales and marketing rights for Xigris in the United States and Puerto Rico, and Lilly sells and markets Xigris in other countries.

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