- May Help Increase Appropriate Early Use in Acute Coronary Syndrome
Patients -
BRIDGEWATER and PRINCETON, N.J., Sept. 27 /PRNewswire-FirstCall/ --
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Bristol-Myers Squibb
Company (NYSE: BMY) announced today that the U.S. Food and Drug
Administration (FDA) has approved a supplemental new drug application
(sNDA) for a 300mg tablet of the antiplatelet PLAVIX(R) (clopidogrel
bisulfate). The PLAVIX 300mg tablet will facilitate the use of the FDA
approved loading dose for appropriate acute coronary syndrome (ACS)
patients as soon as possible after hospital admission. Acute ST-segment
elevation myocardial infarction (STEMI), along with unstable angina (UA)
and non-ST segment elevation myocardial infarction (NSTEMI), are the three
conditions classified as ACS, a major cause of emergency medical care and
hospitalization in the United States.
"The American College of Cardiology-American Heart Association
treatment guidelines for UA/NSTEMI and the American Heart Association
Cardiopulmonary Resuscitation and Emergency Cardiac Care guidelines for ACS
patients (August 2007) recommend a 300mg loading dose of clopidogrel in
conjunction with ASA (aspirin), yet many appropriate ACS patients do not
receive a loading dose of clopidogrel," said Dr. Marc Cohen, F.A.C.C.,
Chief of the Division of Cardiology, and Director of the Cardiology
fellowship at the Newark Beth Israel Medical Center and Professor of
Medicine at the Mount Sinai School of Medicine.
"The 300mg loading dose has been proven effective in a broad ACS
patient population," said Cohen. "A broad ACS population includes not only
UA and NSTEMI, but also STEMI as supported by CURE, CLARITY and COMMIT
trials."
The 300mg tablet is bioequivalent to four 75mg FDA approved tablets of
PLAVIX. The 300mg tablet of clopidogrel will be available in the U.S. later
this year and is also currently under European Medicines Evaluation Agency
(EMEA) review.
About PLAVIX
PLAVIX is a prescription antiplatelet medicine taken once a day that
helps keep platelets in the blood from sticking together and forming clots.
Since its initial approval on November 17, 1997, by the U.S. Food and Drug
Administration, PLAVIX has been prescribed to more than 52 million patients
worldwide. The new 300mg loading dose tablet reinforces the strong
commitment of two research and development pharmaceutical companies
dedicated to improving patient health.
The efficacy and safety of PLAVIX have been established through four
landmark clinical trials involving more than 81,000 patients. Plavix is the
only widely available prescription antiplatelet that provides proven
protection against a future heart attack or stroke for patients with ACS
(UA, NSTEMI, STEMI) and recent MI, recent Stroke, or established peripheral
artery disease.
PLAVIX has demonstrated early and long-term risk reduction for patients
at risk for atherothrombotic events in important clinical trials. In the
CURE trial, patients with unstable angina (UA) and non-ST segment elevation
myocardial infarction (NSTEMI) receiving PLAVIX with aspirin were followed
for up to one year, and in the CAPRIE trial, patients with recent MI,
recent ischemic stroke, or established peripheral artery disease receiving
PLAVIX alone were followed for up to three years.
PLAVIX is marketed worldwide by sanofi-aventis (Paris Bourse: EURONEXT:
SAN; New York: NYSE: SNY) and Bristol-Myers Squibb Company (NYSE: BMY) as
Plavix(R) and Iscover(R).
If you have a stomach ulcer or other condition that causes bleeding,
you should not use Plavix. When taking Plavix alone or with some other
medicines including aspirin, the risk of bleeding may increase so tell your
doctor before planning surgery. And, always talk to your doctor before
taking aspirin or other medicines with Plavix, especially if you've had a
stroke. If you develop fever, unexplained weakness or confusion, tell your
doctor promptly as these may be signs of a rare but potentially
life-threatening condition called TTP, which has been reported rarely,
sometimes in less than 2 weeks after starting therapy. Other rare but
serious side effects may occur.
For more information on PLAVIX visit http://www.plavix.com.
WHO SHOULD RECEIVE Plavix (clopidogrel bisulfate)?
PLAVIX is indicated for the reduction of atherothrombotic events as
follows:
-- Recent Myocardial Infarction (MI), Recent Stroke, or Established
Peripheral Arterial Disease (PAD)
For patients with a history of recent MI, recent stroke, or established
PAD, PLAVIX has been shown to reduce the rate of a combined end point
of new ischemic stroke (fatal or not), new MI (fatal or not), and other
vascular death.
-- Acute Coronary Syndrome (ACS)
For patients with non-ST-segment elevation ACS (unstable angina/non-Q-
wave MI), including patients who are to be managed medically and those
who are to be managed with percutaneous coronary intervention (with or
without stent) or coronary artery bypass graft surgery (CABG), PLAVIX
has been shown to decrease the rate of a combined end point of
cardiovascular death, MI, or stroke as well as the rate of a combined
end point of cardiovascular death, MI, stroke, or refractory ischemia.
For patients with ST-segment elevation acute myocardial infarction,
PLAVIX has been shown to reduce the rate of death from any cause and the
rate of a combined endpoint of death, re-infarction or stroke. This benefit
is not known to pertain to patients who receive primary angioplasty.
Important Risk Information
-- PLAVIX is contraindicated in patients with active pathologic bleeding
such as peptic ulcer or intracranial hemorrhage. PLAVIX should be used
with caution in patients who may be at risk of increased bleeding from
trauma, surgery, or coadministration with NSAIDs or warfarin. (See
CONTRAINDICATIONS and PRECAUTIONS.*)
-- The rates of major and minor bleeding were higher in patients treated
with PLAVIX plus aspirin compared with placebo plus aspirin in clinical
trials. (See ADVERSE REACTIONS.*)
-- As part of the worldwide post marketing experience with PLAVIX, there
have been cases of reported thrombotic thrombocytopenic purpura (TTP),
some with fatal outcome. TTP has been reported rarely following use of
PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious
condition that can be fatal and requires urgent treatment including
plasmapheresis (plasma exchange). (See WARNINGS.*)
-- In clinical trials, the most common clinically important side effects
were pruritus, purpura, diarrhea, and rash; infrequent events included
intracranial hemorrhage (0.4%) and severe neutropenia (0.05%). (See
ADVERSE REACTIONS.*)
*Please see full prescribing information by visiting http://www.plavix.com.
About sanofi-aventis
Sanofi-aventis is one of the world leaders in the pharmaceutical
industry, ranking number one in Europe. Backed by a world-class R&D
organization, sanofi-aventis is developing leading positions in seven major
therapeutic areas: cardiovascular, thrombosis, oncology, metabolic
diseases, central nervous system, internal medicine and vaccines.
Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE:
SNY).
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global pharmaceutical and related health care
products company whose mission is to extend and enhance human life.
SOURCE Bristol-Myers Squibb Company
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Related links:
http://www.bms.com
http://www.plavix.com
CONTACT:
Media, Ken Dominski of Bristol-Myers Squibb,
+1-609-252-5251, ken.dominski@bms.com; or Amy Ba of
sanofi-aventis, +1-908-981-6563, amy.ba@sanofi-aventis.com; or
Investors, John Elicker of Bristol-Myers Squib, +1-212-546-3775,
john.elicker@bms.com; or Felix Lauscher of sanofi-aventis,
+1-212-551-4018, felix.lauscher@sanofi-aventis.com
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