AstraZeneca PLC
10 July 2003
FDA ADVISORY COMMITTEE UNANIMOUSLY RECOMMENDS APPROVAL OF CRESTOR(R)
(rosuvastatin calcium)
AstraZeneca announced today that the Endocrinologic and Metabolic Advisory
Committee to the U.S. Food and Drug Administration (FDA) unanimously voted to
recommend approval for CRESTOR(R) (rosuvastatin calcium) as an adjunct to diet
for the treatment of various lipid disorders including hypercholesterolemia,
mixed dyslipidemia and isolated hypertriglyceridemia. The FDA will now review
the Committee's recommendation and make its final decision on granting marketing
approval for CRESTOR.
'The Committee's unanimous recommendation to approve CRESTOR represents a vote
of confidence in the clinical profile of CRESTOR,' said Howard Hutchinson, Vice
President of Clinical Research, AstraZeneca. 'We believe that once approved,
CRESTOR will provide patients who are untreated or not at their target
cholesterol levels with an important new treatment option in the control of
elevated cholesterol.'
The clinical development programme for CRESTOR is the largest pre-approval
programme ever submitted to evaluate the safety and efficacy of a new statin.
More than 12,500 patients are included in the safety database with more than
4,000 patients exposed to the 40 mg dose. The most commonly reported
treatment-related adverse events were myalgia, abdominal pain, nausea and
asthenia.
CRESTOR belongs to the class of lipid-lowering medications called HMG- CoA
reductase inhibitors, or 'statins' and has been studied in more than 24,000
patients worldwide. CRESTOR is being studied in an extensive clinical outcomes
programme known as GALAXY, which includes more than 19,000 patients from 23
countries.
AstraZeneca licensed worldwide rights to CRESTOR from the Japanese
pharmaceutical company Shionogi & Co., Ltd. CRESTOR was first approved in the
Netherlands in 2002 and approval has recently been granted in 23 other
countries. Launches have occurred in a number of countries, including Canada,
the Netherlands and the United Kingdom.
AstraZeneca (AZN: NYSE) 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 top five
pharmaceutical companies in the world with healthcare sales of over $17.8
billion and leading positions in sales of cardiovascular, gastrointestinal,
oncology, neuroscience and respiratory products. AstraZeneca is listed in the
Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good
Index.
10 July 2003
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- Ends -
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