European Commission Approves Eli Lilly and Company's Xigris for the Treatment of Severe Sepsis.
INDIANAPOLIS--(BUSINESS WIRE)--Aug. 26, 2002
Novel biotech treatment becomes the first proven therapy to
reduce mortality in patients with severe sepsis severe sepsis A condition defined clinically as 'Sepsis associated with organ dysfunction, hypotension, or hypoperfusion abnormalities (which include) …lactic acidosis, oliguria, or an acute alteration in mental status in Europe
Eli Lilly and Company Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States. (NYSE NYSE
See: New York Stock Exchange :LLY) today announced that the European Commission has granted Marketing Authorisation for Xigris(TM) (drotrecogin alfa drotrecogin alfa (activated) Warning - High-alert drug!
Pharmacologic class: Activated protein C (recombinant)
Therapeutic class: Antisepsis drug
(activated)) in all 15-member states of the European Union. This novel, biotech therapy is approved for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. The approval decision follows a positive opinion adopted by the European Committee for Proprietary Medicinal Products (CPMP CPMP Committee for Proprietary Medicinal Products
CPMP Core-Plus Mathematics Project
CPMP Crew Procedures Management Plan (NASA)
CPMP Canadian Project Management Professional
CPMP Corporate Planning and Management Practices ) on Thursday, 30 May 2002. Having received this excellent news, Lilly will make Xigris available in the European Union as soon as possible.
The European Commission based its decision on the results of an international Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the known as PROWESS (Recombinant Human Activated Protein C Human activated protein C is a serine protease which is derived from the two chain vitamin K dependent zymogen.
It is used to inhibit blood coagulation thought the selective inactivation of the cofactors Va and VLLA. Worldwide Evaluation in Severe Sepsis), which were published 8 March 2001, in The New England Journal of Medicine The New England Journal of Medicine (New Engl J Med or NEJM) is an English-language peer-reviewed medical journal published by the Massachusetts Medical Society. It is one of the most popular and widely-read peer-reviewed general medical journals in the world. . Xigris reduced the relative risk of death from severe sepsis by nearly 20 percent in the trial involving 1,690 patients who had sepsis with at least one associated organ dysfunction.
"The approval of Xigris within the European Union means adult patients with severe sepsis will soon have a proven therapy to help reduce mortality from this devastating dev·as·tate
tr.v. dev·as·tat·ed, dev·as·tat·ing, dev·as·tates
1. To lay waste; destroy.
2. To overwhelm; confound; stun: was devastated by the rude remark. condition," said Professor Jean-Louis Vincent, Department of Intensive Care, Erasme Hospital, Brussels, Belgium. "Severe sepsis is an extremely complex and difficult-to-treat condition that can alter the function of the organs and even lead to death."
"Today's approval is a major breakthrough in the treatment of severe sepsis in Europe and brings new hope to patients with the condition and their families," said Richard Pilnik, president of European operations for Lilly. "Lilly has a long-standing commitment to producing innovative treatments to improve patient care so we are delighted to make Xigris available in Europe."
Every day 1,400 people worldwide die from severe sepsis(1), a devastating syndrome characterized by an overwhelming systemic response to infection, which can rapidly lead to organ dysfunction and ultimately death. In European Union (EU) intensive care units (ICU ICU intensive care unit.
intensive care unit
see intensive care unit.
ICU ), severe sepsis and septic shock (severe sepsis combined with low blood pressure) could be associated with the loss of 135,000(2) lives every year and as much as EUR EUR
In currencies, this is the abbreviation for the Euro.
The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 7.6 billion (US$7.6 billion) in patient health costs(3). In Europe, severe sepsis is associated with deaths on a scale similar to that for lung cancer, breast cancer or colon cancer every year.(4)
Xigris received approval from the US Food and Drug Administration on 21 November 2001 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). Since the US approval, Xigris has also been approved in Puerto Rico, Israel, Australia, Argentina, Peru, Romania, Columbia, Mexico, Switzerland, India, Singapore, South Africa and now the European Union.
Xigris is a genetically engineered version of the human Activated Protein C molecule, a naturally occurring protein in the body that helps to balance many of the major forces behind sepsis, including coagulation coagulation (kōăg'ylā`shən), the collecting into a mass of minute particles of a solid dispersed throughout a liquid (a sol), usually followed by the precipitation or (blood-clotting) and suppression of fibrinolysis fibrinolysis /fi·bri·nol·y·sis/ (fi?brin-ol´i-sis) dissolution of fibrin by enzymatic action.fibrinolyt´ic
n. pl. (the body's clot-busting system). Additionally, patients with severe sepsis treated with Xigris had a more rapid decline in interleukin-6 levels, a global marker of inflammation, consistent with a reduction in the inflammatory response. The drug is administered to patients as a one-time, 96-hour infusion within an ICU setting. The precise dosage depends on the weight of the patient.
Bleeding events are common in patients with severe sepsis. In the PROWESS trial, bleeding was the most common adverse reaction associated with Xigris therapy. Serious bleeding events, including intracranial hemorrhage (0.2 percent in Xigris-treated patients and 0.1 percent in placebo-treated patients), were observed during the 28-day study period in 3.5 percent of Xigris-treated patients and 2.0 percent of placebo-treated patients. The difference in serious bleeding occurred primarily during infusion.
About Eli Lilly and Company
Lilly is a leading innovation-driven corporation and is developing a growing portfolio of best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in the US in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs.
This news release contains forward-looking statements that reflect management's current beliefs about the potential for Xigris (drotrecogin alfa (activated)) for the approved indication. However, as with any pharmaceutical under development, there are significant risks and uncertainties in the process of development and regulatory review. There are no guarantees that the product will prove to be commercially successful. For additional information about the factors that affect the company's business, please see Exhibit 99 to the company's latest Form 10-Q, filed August 2002. The company undertakes no duty to update forward-looking statements.
Xigris(TM) (Drotrecogin alfa (activated)), Eli Lilly and Company, Indianapolis, Indiana
(1) Bone RC, Balk balk
the action of a horse when it refuses to obey a command to which it usually responds. See also jibbing. RA, Cerra FB et al. Definitions for sepsis and organ failure and guidelines for the use of innovative therapies for sepsis. Chest: 1992;101: 1644-1655
(2) OECD OECD: see Organization for Economic Cooperation and Development. Health Report (2000)
(3) Davies; Green; Hutton et al. Severe sepsis and septic shock: a European estimate of the cost of illness in ICUs; June 2001; Abstract presented at European Society of Intensive Care Medicine, October 2001.
(4) Davies A et al, June 2000, Severe sepsis and septic shock: a European estimate of the cost of illness in ICUs: Official manuscript.