Xigris Sustains Long-Term Survival in Severe Sepsis Patients; Studies Show Drug Saves Lives Without Lengthening Hospital Stay.Business Editors, Health & Medical Writers INDIANAPOLIS--(BUSINESS WIRE)--Nov. 5, 2002 Xigris(R) (drotrecogin alfa drotrecogin alfa (activated) Warning - High-alert drug! Xigris Pharmacologic class: Activated protein C (recombinant) Therapeutic class: Antisepsis drug (activated)) sustains survival of 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 patients long-term, according to study results presented at the 68th Annual International Scientific Assembly of the American College of Chest Physicians The American College of Chest Physicians (ACCP) is a medical organization consisting of physicians and non-physician specialists in the field of chest medicine, which includes pulmonology, thoracic surgery, and critical care medicine. (ACCP ACCP American College of Chest Physicians ACCP American College of Clinical Pharmacy ACCP Army Correspondence Course Program ACCP Atlantic Climate Change Program ACCP Association of Caribbean Commissioners of Police ACCP Assembly of Caribbean Community Parliamentarians ) in San Diego, Calif. (USA).(1) In one of four abstracts on Xigris presented today, the analysis indicates that the drug also saves lives without lengthening hospital stay compared to those who received standard care alone. Xigris already had proved effective in decreasing the short-term risk of death (28 days) in adults with life-threatening severe sepsis in the landmark PROWESS 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 . 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) first received U.S. FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval for Xigris in November 2001. Since then, it has received approval from regulatory agencies in over 30 other countries, including the 15 member states of the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community . In the EU, Xigris is approved for the treatment of adult patients with severe sepsis with multiple organ dysfunction when added to best standard care. Xigris Sustains Survival Results of a long-term follow-up analysis of PROWESS (n=1,690), conducted from September 2001 until April 2002, showed that reduction in mortality in Xigris-treated patients was sustained over the duration of the study, which followed patients up to two and a half years.(2) "Xigris has already proven that it dramatically improves patients' chances of making it through the most dangerous stage of life-threatening severe sepsis - those first 28 days," said Derek C. Angus, M.D., M.P.H., associate professor of anesthesiology and critical care medicine, University of Pittsburgh (USA), and researcher of one of the studies. "Our new data show that the survival benefit of Xigris is sustained over the long-term. These findings are wonderful news - and offer much-needed hope - for thousands of patients with severe sepsis and their families." No Increase In Hospital Time In the PROWESS Phase III trial, treatment with Xigris plus standard therapy in adults with severe sepsis significantly reduced 28-day all-cause mortality compared with placebo plus standard therapy. The long-term follow-up analysis showed Xigris significantly decreased in-hospital mortality (absolute reduction of 5.2 percent) without incurring extra time in the hospital. Among hospital survivors with known discharge status, patient discharge locations - nursing home, ICU ICU intensive care unit. ICU abbr. intensive care unit ICU see intensive care unit. ICU , other hospital location - were similar between Xigris patients and those patients treated with standard care alone, with about 75 percent of the additional Xigris survivors being accounted for by larger numbers of patients discharged to home.(3) "These data indicate that treatment with Xigris is an investment that pays off," said William Macias, M.D., Ph.D., medical director, Xigris product team, Eli Lilly and Company. "Xigris saves lives and does so without requiring any excess hospital stay, allowing the majority of survivors to go home rather than requiring care at another institution." New Data Reaffirms Efficacy and Safety Profile of Xigris Additional data presented today demonstrate that the survival rate in Xigris-treated patients from all clinical trials to date has remained consistent with the PROWESS clinical trial results. In five clinical trials and two compassionate use compassionate use Pharmacology The use of an agent to treat Pts for whom conventional therapies have failed, or for whom no other drug exists; CU refers to the use of an agent on humanitarian grounds before it has received regulatory–FDA–approval studies of Xigris, the 28-day mortality rate for all patients receiving active treatment was 25.3 percent, comparable to the 24.7 percent Xigris mortality and less than the 30.8 percent placebo mortality demonstrated in the PROWESS trial. A comprehensive review of cumulative safety data from both clinical trials and post-approval experience in the United States and Europe shows that the only significant adverse event associated with Xigris is bleeding, and the data suggest the risk of bleeding is generally manageable. Importantly, this analysis indicates that such events were frequently associated with other hemorrhage-causing factors, such as invasive procedures and thrombocytopenia Thrombocytopenia Definition Thrombocytopenia is an abnormal drop in the number of blood cells involved in forming blood clots. These cells are called platelets. (platelets less than 30,000 per milliliter milliliter /mil·li·li·ter/ (mL) (-le?ter) one thousandth (10-3) of a liter. mil·li·li·ter n. Abbr. ).(4) About Severe Sepsis Severe sepsis occurs when an infection (bacterial, viral, fungal or parasitic) - often the result of trauma, surgery, burns or cancer - triggers a cascade of immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. responses that can lead to acute organ dysfunction and often death. One of every three sepsis patients will die within one month. In European Union (EU) intensive care units (ICU), severe sepsis and septic shock Septic Shock Definition Septic shock is a potentially lethal drop in blood pressure due to the presence of bacteria in the blood. Description Septic shock is a possible consequence of bacteremia, or bacteria in the bloodstream. (severe sepsis combined with low blood pressure) could be associated with the loss of up to 135,000(5) lives every year and as much as EUR EUR In currencies, this is the abbreviation for the Euro. Notes: 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.(6) In Europe, severe sepsis is associated with deaths on a scale similar to that for lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. , breast cancer or colon cancer colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. every year.(7) About Xigris Xigris is a recombinant form of 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. and is administered by intravenous infusion. In the EU, Xigris is approved for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. Safety and efficacy have not been established in pediatric patients with severe sepsis. In addition to the ADDRESS (Administration of Drotrecogin alfa (activated) in Early Severe Sepsis) trial investigating the use of Xigris in lower-risk patients, Lilly is undertaking trials of Xigris in children with severe sepsis, and investigating the concomitant use of low-dose heparin with Xigris. 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, a leading innovation-driven corporation, 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 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 future studies will confirm the results reported in this press release or 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(R)(Drotrecogin alfa (activated), Eli Lilly and Company) 1. Angus, Laterre, Helterbrand, Ball, Garg, Bernard. The effects of (drotrecogin alfa (activated)) on long-term survival after severe sepsis. Abstract presented at CHEST, 2002 2. Angus D, et al. The Effects of Drotrecogin Alfa (Activated) on Long-Term Survival After Sepsis. CHEST, Oct. 2002, Vol. 122, No. 4 (suppl), p.51S. 3. Laterre PF, et al. The Effects of Drotrecogin Alfa (Activated) on Hospital Mortality, Length of Stay, and Discharge Location. CHEST, Oct. 2002, Vol. 122, No. 4 (suppl), p.51S. 4. Bernard C., et al. Drotrecogin Alfa (Activated) Safety Update. CHEST, Oct. 2002, Vol. 122, No. 4 (suppl), p. 50S. 5. OECD OECD: see Organization for Economic Cooperation and Development. Health Report (2000). 6. 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. 7. Davies A et al, June 2000, Severe sepsis and septic shock: a European estimate of the cost of illness in ICUs: Official manuscript. |
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