9th Nov 2007 07:04
AstraZeneca PLC09 November 2007 CRESTOR(R) 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) hasapproved CRESTOR(R) (rosuvastatin calcium) as an adjunct to diet to slow theprogression of atherosclerosis in patients with elevated cholesterol. This newindication gives CRESTOR an important differentiator from competitors in thecholesterol-lowering marketplace. The submission package to the FDA was based largely on the results of a pivotalstudy called METEOR (Measuring Effects on intima media Thickness: an EvaluationOf Rosuvastatin) which measured the effects of CRESTOR on plaque build-up in thearteries using carotid intima-media thickness (CIMT) and demonstrated a slowingof 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 toaddress important unanswered questions in statin research and to investigate theimpact of CRESTOR on cardiovascular risk reduction and patient outcomes. Todate, the GALAXY Programme has recruited more than 69,000 subjects in more than55 countries around the world. The new CRESTOR label conforms to the FDA's revised, easy-to-read formatdesigned to draw physicians' attention to the most important pieces of druginformation in an effort to manage the risks of medication use and reducemedical errors. About Atherosclerosis Atherosclerosis is the progressive buildup of plaque - the fatty deposits andother cells - in the inner walls of the arteries. The condition is a consequenceof elevated cholesterol and for many it is a silent disease, with no visiblesigns or symptoms. The disease can begin in early adulthood and continues toprogress for the rest of a person's life. Despite the serious nature ofatherosclerosis, 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 patientswith primary hyperlipidaemia or mixed dyslipidaemia. CRESTOR is also indicatedas an adjunct to diet to slow the progression of atherosclerosis in adultpatients as part of a treatment strategy to lower Total-C and LDL-C to targetlevels. CRESTOR has not be determined to prevent heart disease, heart attacksor strokes. For patients with hypercholesterolaemia and mixed dyslipidaemia,the usual recommended starting dose of CRESTOR is 10 mg. The 40 mg dose ofCRESTOR is reserved for only those patients who have not achieved their LDL-Cgoal utilising the 20 mg dose of CRESTOR once-daily. When initiating statintherapy or switching from another statin therapy, the appropriate CRESTORstarting dose should first be utilised, and only then titrated according to thepatients individualised goal of therapy. AstraZeneca licensed worldwide rightsto 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 theresearch, development, manufacture and marketing of prescription pharmaceuticalsand the supply of healthcare services. It is one of the world's leadingpharmaceutical companies with healthcare sales of $26.47 billion and leadingpositions in sales of gastrointestinal, cardiovascular, neuroscience,respiratory, oncology and infection products. AstraZeneca is listed in the DowJones Sustainability Index (Global) as well as the FTSE4Good Index. 9 November 2007 Media Enquiries: Steve Brown, +44 207 304 5033 (24 hours)Edel McCaffrey, +44 207 304 5034 (24 hours) Investor Enquiries:Jonathan Hunt, +44 207 304 5087Ed Seage, +1 302 886 4065Karl Hard, +44 207 304 5322Jorgen Winroth, +1 212 579 0506Mina Blair, +44 20 7304 5084Peter Vozzo, (MedImmune) +1 301 398 4358 -ENDS- This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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