AstraZeneca PLC
13 August 2003
CRESTOR(R) RECEIVES FDA APPROVAL
CRESTOR Significantly Lowers LDL Cholesterol by As Much As 63%
AstraZeneca announced today that its new cholesterol-lowering medication,
CRESTOR(R) (rosuvastatin calcium), which has been shown to lower LDL-cholesterol
by up to 63 percent, has received approval from the U.S. Food and Drug
Administration (FDA) as an adjunct to diet for the treatment of various lipid
disorders including primary hypercholesterolemia, mixed dyslipidemia and
isolated hypertriglyceridemia. This follows the successful Advisory Committee
Meeting held in the US on 9th July 2003 where the Committee voted unanimously to
recommend the approval of CRESTOR.
CRESTOR is the newest member of the cholesterol-lowering statin (HMG-CoA
reductase inhibitors) class of drug therapy. In addition to its LDL
(low-density lipoprotein) or 'bad' cholesterol lowering effects, CRESTOR has
been shown to provide a significant increase in HDL (high-density lipoprotein)
or 'good' cholesterol.
'We are delighted with the approval of CRESTOR in the United States,' said Sir
Tom McKillop, Chief Executive Officer of AstraZeneca. 'We believe that CRESTOR
offers an important new treatment option for patients who are either untreated
or not at target cholesterol levels.'
The FDA has approved the recommended usual starting dose of CRESTOR to be 10 mg
once daily with a dose range of 5 to 40 mg available. Therapy with CRESTOR
should be individualised according to goal of therapy and response. For
patients with marked hypercholesterolemia (LDL-C >190 mg/dL) and aggressive
lipid targets, a 20 mg start dose may be considered, and for special populations
a 5 mg dose is also available.
The clinical development program for CRESTOR is the largest program ever
submitted to initially evaluate a statin. In multiple clinical studies, CRESTOR
has been shown to be more effective in lowering LDL-cholesterol (LDL-C or 'bad
cholesterol') than currently prescribed statins. CRESTOR 10mg gets
significantly more patients to their LDL-C goal (both NCEP ATP III (US) and
European) than atorvastatin 10mg and, in addition to the dramatic reductions
seen in LDL-C, CRESTOR produces a significant increase in HDL-C ('good
cholesterol'), as well as reducing total cholesterol and triglycerides.
Evidence collected from over 24,000 patients who have taken CRESTOR demonstrates
that it is well tolerated with a safety profile comparable to that of other
statins.
Guidelines issued by the National Cholesterol Education Program's Adult
Treatment Panel III have substantially increased the number of patients eligible
for cholesterol-lowering drug therapy from approximately 13 million to 36
million. Currently, it is estimated that more than 20 million Americans have an
LDL goal of <100 mg/dL, and it is estimated that only about one third of treated
patients reach their LDL goal. Cardiovascular disease is the leading cause of
death in the United States. According to the American Heart Association, more
than 2,600 Americans die from cardiovascular diseases every day - an average of
one death every 33 seconds.
The global statin market is estimated to be worth approximately $20 billion and
growing at a rate of around 13 per cent annually. CRESTOR was first approved in
the Netherlands in 2002 and has since been approved in 23 other countries.
Launches have occurred in a number of countries, including Canada, the
Netherlands and the United Kingdom.
13 August 2003
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Chris Major, Tel: +44 (0) 207 304 5028
Investor Relations:
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Jorgen Winroth, Tel: +1 212 581 8720
NOTES TO EDITORS
*National Cholesterol Education Program's Adult Treatment Panel III
• Full US prescribing information for CRESTOR is available at
www.astrazeneca-us.com
• AstraZeneca licensed worldwide rights to CRESTOR from the Japanese
pharmaceutical company Shionogi & Co Ltd, the pharmaceutical company that
discovered the drug, in April 1998.
• CRESTOR is indicated as an adjunct to diet to reduce elevated total-C,
LDL-C, ApoB, nonHDL-C, and TG levels and to increase HDL-C in patients with
primary hypercholesterolemia (heterozygous familial and nonfamilial) and
mixed dyslipidemia (Fredrickson Type IIa and IIb); as an adjunct to diet for
the treatment of patients with elevated serum TG levels (Fredrickson Type
IV); and to reduce LDL-C and total-C in patients with homozygous familial
hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg,
LDL apheresis) or if such treatments are unavailable.
• CVD is estimated to account for a third of all deaths globally and is
the leading cause of mortality in Europe and the US. Over 16.6 million
deaths each year are due to CVD (more than 45,000 deaths every day, and
almost 32 deaths each minute) In Europe, about half of all deaths from CVD
are from CHD and nearly one-third are from stroke.
• For further information please see www.astrazenecapressoffice.com
-Ends-
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