INDIANAPOLIS — Eli Lilly is withdrawing one of its drugs from the market after clinical trials showed it to be ineffective.
The drug maker announced Tuesday the withdrawal of Xigris (drotrecogin alfa [activated]) from all markets following results of the "PROWESS-SHOCK" study, which found that it did not produce a statistically significant reduction in 28-day, all-cause death in patients with septic shock. The company said there were no new findings regarding the drug's safety profile.
The drug was used to treat sepsis, a common and deadly disease that can develop as a complication after such illnesses as bacterial infections and pneumonia, and results from an overwhelming systemic response to infection that can lead to organ failure and death.
"[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," Lilly SVP and chief medical officer Timothy Garnett said. "Patients currently receiving treatment with Xigris should have treatment discontinued, and Xigris treatment should not be initiated for new patients."