播種性血管内凝固症候群（DIC）を合併した重症敗血症治療の治療に，活性化プロテインCの効力はないとして，
Xigris®の販売の中止が，Eli Lilly and Company より宣言されました。
これは，PROWESS-SHOCK TRIAL: A PROTOCOL OVERVIEW AND PERSPECTIVESの結果を受けたものです。
対照群の治療成績が極めて良くなっています（24.2%）が，当教室もよりDICの病態をも解明する必然が出てきました。
現在，若手の世界連携で動いているVAHGの活動の中で，血管内皮細胞炎症性DICの本質を解明し，新規創薬を提唱する必然が出てきました。
NDIANAPOLIS, Oct. 25, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announces withdrawal of its Xigris® [drotrecogin alfa (activated)] product in all markets following results of the PROWESS-SHOCK study, which showed the study did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock. The company is working with regulatory agencies on this withdrawal, and is in the process of notifying health care professionals and clinical trial investigators.
"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," said Timothy Garnett, M.D., Lilly's Senior Vice President and Chief Medical Officer. "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."
Xigris was approved in the United States by the Food and Drug Administration (FDA) in November 2001, and was licensed in the European Union in 2002. The PROWESS-SHOCK study was initiated in March of 2008 as a condition for continued market authorization in Europe. Lilly committed to conduct a new placebo-controlled clinical trial to help refine appropriate patient identification for treatment with Xigris and to confirm the benefit-risk profile of the product.
BioCritica, Inc. has sales and marketing rights for Xigris in the United States and Puerto Rico, and Lilly sells and markets Xigris in other countries.
Patients, physicians, pharmacists, or other healthcare professionals with additional questions about Xigris should contact The Lilly Answer Center at 1-800-LillyRx or visit www.Lilly.com.
About Severe Sepsis
Sepsis is a common and deadly disease(1). Severe sepsis can develop as a complication after common illnesses such as pneumonia and bacterial infections, and is characterized by an overwhelming systemic response to infection which can rapidly lead to organ failure and ultimately death.
About Xigris
Xigris (drotrecogin alfa [activated]) is a recombinant form of human Activated Protein C. It is administered by intravenous infusion. Based on the results of the PROWESS study the U.S. Food and Drug Administration approved Xigris in November 2001 for the reduction of mortality in adult patients with severe sepsis who have a high risk of death (e.g., as determined by APACHE II). Xigris is not indicated in adult patients with severe sepsis and a lower risk of death (e.g., APACHE II score <25). Xigris is not indicated in pediatric patients. In 2002, the EMA licensed Xigris for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care.
SHOCK, Vol. 34, Supplement 1, pp. 48Y53, 2010
PROWESS-SHOCK TRIAL: A PROTOCOL OVERVIEW AND PERSPECTIVES
Elie´zer Silva,* Luiz Francisco Poli de Figueiredo,† and Fernando Colombari*
*Intensive Care Unit, Hospital Israelita Albert Einstein; and †Faculdade de Medicina,
Universidade de Sa˜o Paulo, Sa˜o Paulo, Brazil
ABSTRACT―Sepsis remains a challenge for intensive care physicians, as it keeps up with high mortality rate in spite of the
high costs associated with its treatment. Several studies indicate that the infusion of Drotrecogin-alpha activated (DrotAA)
reduce mortality in patients at high risk of death when administered early and secured the appropriate initial treatment of
sepsis as recommended by Surviving Sepsis Campaign. Europe and United States of America differ regarding the criteria of
high risk of death in sepsis, two or more organ dysfunctions and Acute Physiology and Chronic Health Evaluation 25 or
more, respectively. In addition to varied definitions of high risk of death for inclusion of patients in sepsis studies, the
possibility of bleeding related to drug use and intrinsic limitations related to study design led the Company to develop a new
randomized, multinational, placebo-controlled, double-blind study to assess the effectiveness of drug in patients with septic
shock in adults.
Xigris®の販売の中止が，Eli Lilly and Company より宣言されました。
これは，PROWESS-SHOCK TRIAL: A PROTOCOL OVERVIEW AND PERSPECTIVESの結果を受けたものです。
対照群の治療成績が極めて良くなっています（24.2%）が，当教室もよりDICの病態をも解明する必然が出てきました。
現在，若手の世界連携で動いているVAHGの活動の中で，血管内皮細胞炎症性DICの本質を解明し，新規創薬を提唱する必然が出てきました。
NDIANAPOLIS, Oct. 25, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announces withdrawal of its Xigris® [drotrecogin alfa (activated)] product in all markets following results of the PROWESS-SHOCK study, which showed the study did not meet the primary endpoint of a statistically significant reduction in 28-day all-cause mortality in patients with septic shock. The company is working with regulatory agencies on this withdrawal, and is in the process of notifying health care professionals and clinical trial investigators.
"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," said Timothy Garnett, M.D., Lilly's Senior Vice President and Chief Medical Officer. "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."
Xigris was approved in the United States by the Food and Drug Administration (FDA) in November 2001, and was licensed in the European Union in 2002. The PROWESS-SHOCK study was initiated in March of 2008 as a condition for continued market authorization in Europe. Lilly committed to conduct a new placebo-controlled clinical trial to help refine appropriate patient identification for treatment with Xigris and to confirm the benefit-risk profile of the product.
BioCritica, Inc. has sales and marketing rights for Xigris in the United States and Puerto Rico, and Lilly sells and markets Xigris in other countries.
Patients, physicians, pharmacists, or other healthcare professionals with additional questions about Xigris should contact The Lilly Answer Center at 1-800-LillyRx or visit www.Lilly.com.
About Severe Sepsis
Sepsis is a common and deadly disease(1). Severe sepsis can develop as a complication after common illnesses such as pneumonia and bacterial infections, and is characterized by an overwhelming systemic response to infection which can rapidly lead to organ failure and ultimately death.
About Xigris
Xigris (drotrecogin alfa [activated]) is a recombinant form of human Activated Protein C. It is administered by intravenous infusion. Based on the results of the PROWESS study the U.S. Food and Drug Administration approved Xigris in November 2001 for the reduction of mortality in adult patients with severe sepsis who have a high risk of death (e.g., as determined by APACHE II). Xigris is not indicated in adult patients with severe sepsis and a lower risk of death (e.g., APACHE II score <25). Xigris is not indicated in pediatric patients. In 2002, the EMA licensed Xigris for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care.
SHOCK, Vol. 34, Supplement 1, pp. 48Y53, 2010
PROWESS-SHOCK TRIAL: A PROTOCOL OVERVIEW AND PERSPECTIVES
Elie´zer Silva,* Luiz Francisco Poli de Figueiredo,† and Fernando Colombari*
*Intensive Care Unit, Hospital Israelita Albert Einstein; and †Faculdade de Medicina,
Universidade de Sa˜o Paulo, Sa˜o Paulo, Brazil
ABSTRACT―Sepsis remains a challenge for intensive care physicians, as it keeps up with high mortality rate in spite of the
high costs associated with its treatment. Several studies indicate that the infusion of Drotrecogin-alpha activated (DrotAA)
reduce mortality in patients at high risk of death when administered early and secured the appropriate initial treatment of
sepsis as recommended by Surviving Sepsis Campaign. Europe and United States of America differ regarding the criteria of
high risk of death in sepsis, two or more organ dysfunctions and Acute Physiology and Chronic Health Evaluation 25 or
more, respectively. In addition to varied definitions of high risk of death for inclusion of patients in sepsis studies, the
possibility of bleeding related to drug use and intrinsic limitations related to study design led the Company to develop a new
randomized, multinational, placebo-controlled, double-blind study to assess the effectiveness of drug in patients with septic
shock in adults.
アクセス
トータル
ランキング
