WILMINGTON, Del., Nov. 9 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE:
AZN) announced today that the U.S. Food and Drug Administration (FDA) has
approved CRESTOR(R) (rosuvastatin calcium) as an adjunct to diet to slow
the progression of atherosclerosis in patients with elevated cholesterol.
This new indication gives CRESTOR an important differentiator from
competitors in the cholesterol-lowering marketplace.
"This new indication allows us to share what we've learned in clinical
trials -- that even in people with low Framingham risk score, and early
signs of atherosclerosis, the disease progresses if untreated," said Mike
Tilton, AstraZeneca's Vice President of Cardiovascular Primary Care. "In
the METEOR trial, patients with hyperlipidemia who took CRESTOR, overall
experienced no significant progression of atherosclerosis."
The submission package to the FDA was based largely on the results of a
pivotal study called METEOR (Measuring Effects on intima media Thickness:
an Evaluation Of Rosuvastatin) which measured the effects of CRESTOR on
plaque build-up in the arteries using carotid intima-media thickness (CIMT)
and demonstrated a slowing of progression of atherosclerosis in people with
early signs of the disease, elevated LDL cholesterol, and low
cardiovascular risk, taking CRESTOR 40 mg.
The METEOR study is part of AstraZeneca's GALAXY Program, a large,
comprehensive, long-term and evolving global research initiative designed
to address important unanswered questions in statin research and to
investigate the impact of CRESTOR on cardiovascular risk reduction and
patient outcomes. To date, the GALAXY Program has recruited more than
69,000 subjects in more than 55 countries around the world.
The new CRESTOR label conforms to the FDA's revised, easy-to-read
format designed to draw physicians' attention to the most important pieces
of drug information in an effort to manage the risks of medication use and
reduce medical errors.
About Atherosclerosis
Atherosclerosis is the progressive buildup of plaque -- the fatty
deposits and other cells -- in the inner walls of the arteries. The
condition is a consequence of elevated cholesterol and for many it's a
silent disease, with no visible signs or symptoms. The disease can begin in
early adulthood and continues to progress for the rest of a person's life.
Despite the serious nature of atherosclerosis, many people do not
understand how it develops and progresses.
About CRESTOR
CRESTOR is indicated as adjunctive therapy to diet to reduce elevated
Total-C, LDL-C, ApoB, nonHDL-C, and triglycerides and to increase HDL-C in
adult patients with primary hyperlipidemia or mixed dyslipidemia. CRESTOR
is also indicated as an adjunct to diet to slow the progression of
atherosclerosis in adult patients as part of a treatment strategy to lower
Total-C and LDL-C to target levels. CRESTOR has not been determined to
prevent heart disease, heart attacks, or strokes. For patients with
hypercholesterolemia and mixed dyslipidemia, the usual recommended starting
dose of CRESTOR is 10 mg. The 40-mg dose of CRESTOR is reserved only for
those patients who have not achieved their LDL-C goal utilizing the 20-mg
dose of CRESTOR once daily. When initiating statin therapy or switching
from another statin therapy, the appropriate CRESTOR starting dose should
first be utilized, and only then titrated according to the patient's
individualized goal of therapy. AstraZeneca licensed worldwide rights to
CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.
For more information about CRESTOR, including full Prescribing
Information, visit http://www.crestor.com .
Important Safety Information
CRESTOR is contraindicated in patients with a known hypersensitivity to
any component of the product and in patients with active liver disease or
unexplained persistent elevations of hepatic transaminase, in women who are
pregnant or may become pregnant, and in nursing mothers. Cases of myopathy
and rhabdomyolysis with acute renal failure secondary to myoglobinuria have
been reported with drugs in this class, including CRESTOR. These risks can
occur at any dose level but are increased at the highest dose (40 mg). The
risk of myopathy during treatment with CRESTOR may be increased with
concurrent administration of some other lipid-lowering therapies (fibrates
or niacin), gemfibrozil, cyclosporine, or lopinavir/ritonavir. Combination
therapy with rosuvastatin and gemfibrozil should be avoided. CRESTOR should
be prescribed with caution in patients with predisposing factors for
myopathy, such as renal impairment, advanced age, and inadequately treated
hypothyroidism. Patients should be advised to promptly report unexplained
muscle pain, tenderness, or weakness, particularly if accompanied by
malaise or fever. It is recommended that liver function tests be performed
before and at 12 weeks following both the initiation of therapy and any
elevation of dose, and periodically (e.g., semiannually) thereafter.
CRESTOR is generally well-tolerated. The most frequent adverse reactions
thought to be related to CRESTOR were headache (3.7%), myalgia (3.1%),
abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%).
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the
world's leading pharmaceutical companies with healthcare sales of $26.47
billion and leading positions in sales of gastrointestinal, cardiovascular,
neuroscience, respiratory, oncology and infection products. AstraZeneca is
listed in the Dow Jones Sustainability Index (Global) as well as the
FTSE4Good Index.
In the United States, AstraZeneca is a $12.44 billion healthcare
business with more than 12,000 employees. For nearly three decades,
AstraZeneca has offered drug assistance programs side by side with its
medicines, and over the past five years, has provided over $3 billion in
savings to more than 1 million patients throughout the U.S. and Puerto
Rico. AstraZeneca has been named one of the "100 Best Companies for Working
Mothers" by Working Mother magazine and is the only large pharmaceutical
company named to FORTUNE magazine's 2007 list of "100 Best Companies to
Work For." In 2006, for the fifth consecutive year, Science magazine named
AstraZeneca a "Top Employer" on its ranking of the world's most respected
biopharmaceutical employers.
For more information about AstraZeneca, please visit:
http://www.astrazeneca-us.com
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Related links:
http://www.astrazeneca-us.com
http://www.crestor.com
http://www.prnewswire.com/comp/985887.html/
CONTACT:
Christopher Sampson, +1-302-885-8908,
Christopher.Sampson@astrazeneca.com, or Michele Pelkowski,
+1-302-885-4055, Michele.Pelkowski@astrazeneca.com, both of
AstraZeneca
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