Crestor® now indicated to slow the progression of atherosclerosis in patients with elevated cholesterol

Crestor® now indicated to slow the progression of atherosclerosis in patients
with elevated cholesterol

AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has
approved CRESTOR® (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 have 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 hyperlipidaemia 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 Programme, 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 Programme 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 is 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 hyperlipidaemia or mixed dyslipidaemia.  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 be determined to prevent heart disease, heart attacks
or strokes.  For patients with hypercholesterolaemia and mixed dyslipidaemia,
the usual recommended starting dose of CRESTOR is 10 mg.  The 40 mg dose of
CRESTOR is reserved for only those patients who have not achieved their LDL-C
goal utilising 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 utilised, and only then titrated according to the
patients individualised 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 www.crestor.com

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.  

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