AstraZeneca PLC
20 May 2003
CRESTOR(R) -- NEW DATA AND REGULATORY UPDATE
New Data
AstraZeneca announced today that an updated review of the safety profile for
CRESTOR(R) (rosuvastatin) 10-40mg in over 15,000 patients, will be presented as
a poster at the 2nd annual meeting of the Asia Pacific Scientific Forum, in
Honolulu; June 8-10, 2003. The abstract, which covers data as of October, 2002,
will be available online today via the conference website at:
http://www.americanheart.org/presenter.jhtml?identifier=3000411
The data confirm the benefit-risk profile of CRESTOR, with the authors
concluding that: 'Compared with other statins, rosuvastatin 10-40mg is highly
beneficial in terms of lipid profiles and goal attainment with a reassuring
safety profile.'
Regulatory Update
The US Food and Drug Administration (FDA) today confirmed that CRESTOR will be
reviewed by the FDA's Endocrinologic and Metabolic Advisory Committee on July 9,
2003. AstraZeneca is confident in the regulatory package submitted for CRESTOR
and looks forward to presenting data from the extensive clinical trial program,
confirming its efficacy and safety.
CRESTOR was first approved in the Netherlands in 2002 and has now successfully
completed the Mutual Recognition Procedure in 13 other European countries.
CRESTOR is awaiting approval in the US, Japan and other markets. Launches in
Canada, the Netherlands and the UK have occurred, and further launches are
scheduled, following national marketing authorisations and pricing and
reimbursement discussions.
20 May 2003
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
Mina Blair Robinson, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
-Ends-
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