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New Treatment Guidelines Cite ReoPro(R) Favorably for PCI in
Acute Heart Attack Patients
INDIANAPOLIS, July 16 /PRNewswire-FirstCall/ -- New guidelines issued by the
American College of Cardiology and the American Heart Association are in favor
of using ReoPro(R) (abciximab) in acute heart attack patients (ST- Elevation
Myocardial Infarction or STEMI) who are having a balloon or stenting procedure
(PCI). ReoPro, a glycoprotein IIb/IIIa inhibitor, is indicated for adjunctive
use with PCI for the prevention of cardiac ischemic complications in patients
undergoing this procedure.
"ACC/AHA Guidelines for the Management of Patients with ST-Elevation Myocardial
Infarction - Executive Summary" was published July 13 in Circulation. In
addition, the guidelines will be featured in the July 21 issue of the Journal
of the American College of Cardiology. The last revision of the guidelines
related to the treatment of patients with acute heart attacks was in 1999.
Cardiologists use these guidelines to help manage more severe heart attack
patients.
ReoPro received the "Class IIa, level of evidence B" recommendation in the new
guidelines, meaning that the treatment is useful/effective but may have some
conflicting evidence from a clinical trial. The guidelines are in favor of
starting treatment with ReoPro as early as possible before primary PCI (with or
without stenting) in patients with STEMI. Dosing and administration
instructions for ReoPro indicate that ReoPro should be administered 10-60
minutes before the start of PCI.
"We are very pleased to get this recommendation. We believe ReoPro in
conjunction with PCI is an excellent choice to help manage acute heart attack
patients as well as many other patients who are having a balloon or stenting
procedure," said Dr. Mark Effron, medical director, U.S. Acute Care, Eli Lilly
and Company. "ReoPro has been studied extensively, including more than five
randomized clinical trials in ST-elevation MI, as well as many other trials in
a variety of patient types."
Nationwide, an estimated 500,000 people have an acute heart attack annually,
according to the ACC. Aggressive recognition and treatment of acute heart
attacks, as outlined in these guidelines, including the use of ReoPro with PCI,
may contribute to a reduction in death and complications from this disease.
About ReoPro
ReoPro is a member of a class of drugs known as glycoprotein (GP) IIb/IIIa
inhibitors that target the platelet component of blood clots and reduce the
complications associated with blood flow restrictions during coronary
intervention, including angioplasty and stenting. In these settings, ReoPro
prevents complications associated with thrombi (blood clots), and has shown
this in clinical trials by reducing the incidence of a composite of mortality,
repeat heart attacks, or repeat PCI. ReoPro has the potential to increase the
risk of bleeding, particularly in the presence of anti-coagulation agents,
e.g., from heparin or other anticoagulants. The risk of a major bleed due to
ReoPro therapy is increased in patients receiving thrombolytics and should be
weighed against the anticipated benefits.
Because ReoPro may increase the risk of bleeding, its use is contraindicated in
the following clinical situations: active internal bleeding, recent (within 6
weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical
significance, history of cerebrovascular accident (CVA) within 2 years, or CVA
with a significant residual neurological deficit, bleeding diathesis,
administration of oral anticoagulants within 7 days unless prothrombin time <
/= 1.2 times control, thrombocytopenia (< 100,000 cells/ micro L), recent
(within 6 weeks) major surgery or trauma, intracranial neoplasm, arteriovenous
malformation, or aneurysm, severe uncontrolled hypertension, presumed or
documented history of vasculitis, use of intravenous dextran before
percutaneous coronary intervention, or intent to use it during intervention,
known hypersensitivity to any component of this product or to murine proteins.
In clinical trials, patients treated with ReoPro were more likely than patients
who received placebo to experience decreases in platelet counts, including
severe thrombocytopenia.
Administration of ReoPro may result in the formation of human anti chimeric
antibodies (HACA) that could potentially cause allergic or hypersensitivity
reactions (including anaphylaxis), thrombocytopenia, or diminished benefit upon
readministration. ReoPro readministration may be associated with an increased
incidence and severity of thrombocytopenia. This increased risk was associated
with a history of thrombocytopenia on prior ReoPro exposure, a positive HACA
assay at baseline, and readministration within 30-days.
Full prescribing information for ReoPro is available by calling 1-800-545-5979.
ReoPro was developed by Centocor of Malvern, Pa., USA, and is manufactured by
Centocor, B.V., in Leiden, the Netherlands. Eli Lilly and Company markets and
distributes the product worldwide except in Japan.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and 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. Additional information
about Lilly is available at http://www.lilly.com/ .
About Centocor
Centocor is a leading biopharmaceutical company that creates, acquires and
markets cost-effective therapies that yield long-term benefits for patients and
the health care community. Its products, developed primarily through
monoclonal antibody technology, help physicians deliver innovative treatments
to improve human health and restore patients' quality of life. Centocor is a
wholly owned subsidiary of Johnson & Johnson, a worldwide leader of health care
products.
ReoPro(R) (abciximab, Centocor), Lilly
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20040716/CENTOCORLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20040716/CENTOCORLOGO
DATASOURCE: Eli Lilly and Company
CONTACT: Janice Chavers of Eli Lilly and Company, +1-317-651-6253