INDIANAPOLIS, Oct. 18 /PRNewswire-FirstCall/ -- Eli Lilly and Company has always strived, and continues to strive, to do what's right for the patient and health care community.
Our educational grant support for critical care and severe sepsis came at a crucial time for the scientific and patient communities. When Lilly's Xigris(R) was shown to reduce mortality in this deadly condition, this marked the first time in more than 20 years of research in the field in which a treatment had shown such promise. With this emerging science and the FDA's subsequent approval of Xigris(R) to treat this vulnerable patient population, Lilly felt a clear obligation to support educational efforts in the health care community, both on the disease state overall and on the medicine to ensure appropriate use.
The realities of critical care medicine at the time showed that educational needs surrounding sepsis, as well as Xigris(R) itself, were significant. For example, existing definitions of severe sepsis were not widely used and the understanding of the disease was continuing to evolve. Additionally, there was a need to make sure Xigris(R) was used appropriately. Not all patients with severe sepsis are candidates for Xigris(R), so it was essential to help physicians identify which patients would be at a high risk of death, the approved patient population for Xigris(R). Lilly as well as the academic community recognized the importance of and need for treatment guidelines for severe sepsis.
As an integral participant in patient health care, it is important for Lilly to support advocacy and professional organizations to advance understanding of patient care. Lilly believes that providing educational grants to third-party organizations, such as the Surviving Sepsis Campaign, whose work led to the development of treatment guidelines for severe sepsis, is proper. We do not believe that Lilly had any role in the development of guideline content, beyond funding the initiative. The campaign worked independently and autonomously, and our funding for these grants was openly disclosed.
We are taking this very seriously and we have looked at the issue very closely. The standards for Lilly grants, then as now, are high, and we will continue to examine policies and procedures to ensure that our behavior in all things match our core values -- respect for people, integrity and excellence.
About Xigris(R)
Xigris(R) (drotrecogin alfa [activated]) from Eli Lilly and Company is a recombinant form of human Activated Protein C. It is administered by intravenous infusion and is available in 5 mg and 20 mg vials. Xigris(R) is indicated for the reduction of mortality in adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (e.g., as determined by APACHE II).
Xigris(R) is not indicated for adult patients with severe sepsis and a lower risk of death. Safety and efficacy have not been established in pediatric patients with severe sepsis. Bleeding events are common in patients with severe sepsis. In the PROWESS trial, bleeding was the most common adverse reaction associated with Xigris(R) therapy. The serious bleeding event rate in Xigris(R)-treated patients during infusion was 2.4 percent compared to 1.0 percent in the placebo-treated patients.
For complete Xigris(R) (drotrecogin alfa [activated]) prescribing information and labeling, call 800-423-2313 or visit http://www.xigris.com/.
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