Eli Lilly is voluntarily withdrawing Xigris (drotrecogin alfa (activated)) from the market worldwide after a clinical trial (PROWESS-SHOCK trial) showed no survival benefit for sepsis and septic shock patients. In a Safety Announcement the US FDA (Food and Drug Administration) wrote that Xigris treatment should be stopped in patients being treated with the drug, and no new patients should be prescribed Xigris.

Health care providers, clinics and hospitals have been asked to return any remaining Xigris stocks to their suppliers.

This recent trial involved 1,696 patients. They were randomly selected into two groups:

  • The Xigris group – 851 patients were administered Xigris
  • The placebo group – 845 patients were administered a placebo (dummy drug)

After carrying out a preliminary analysis, Eli Lilly reported the following to the FDA and other regulatory bodies around the world:

  • Xigris group – 28-day all cause mortality rate, 26.4%
  • Placebo group – 28-days all cause mortality rate, 24.2%

Sepsis, also known as blood stream infection, or blood poisoning is when infectious organisms, such as bacteria (bacteremia) or their toxins enter the bloodstream or other tissue on the body. Sepsis can be serious and life-threatening. Severe sepsis is a whole-body (systemic) inflammatory response, with infection, plus the presence of organ dysfunction.

As a result of the Xigris global withdrawal, Eli Lilly has had to update its full-year 2011 financial guidance.

Today, in a communiqué, the company wrote:

Lilly expects to incur a charge in the fourth quarter of 2011 for asset impairments and contractual commitments related to Xigris. The exact amount of the charge has not yet been determined, but is estimated to be in the range of $75.0 million to $95.0 million (pre-tax), or approximately $.05 per share (after tax).

Lilly’s full-year 2011 earnings per share guidance on a non-GAAP basis remains unchanged at $4.30 to $4.35. On a reported basis, including the Xigris asset impairment charge, Lilly now expects its full-year 2011 earnings per share to be in the range of $3.84 to $3.89.

Lilly’s Senior Vice President and Chief Medical Officer, Timothy Garnett, M.D., said:

“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. 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.”

The US FDA approved Xigris in November 2001, as did the European Union the following year. This latest trial started in March 2008 after European regulatory authorities said it was a requirement for continued authorization.

Written by Christian Nordqvist