FDA Approves New Indication for Crestor
Crestor Now Indicated to Slow the Progression of Atherosclerosis in Patients With Elevated Cholesterol
WILMINGTON, Del., November 09, 2007 /PRNewswire-FirstCall/ -- 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've 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 hyperlipidemia 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 Program, 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 Program 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.
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's 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.
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 hyperlipidemia or mixed dyslipidemia. 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 been determined to prevent heart disease, heart attacks, or strokes. For patients with hypercholesterolemia and mixed dyslipidemia, the usual recommended starting dose of Crestor is 10 mg. The 40-mg dose of Crestor is reserved only for those patients who have not achieved their LDL-C goal utilizing 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 utilized, and only then titrated according to the patient's individualized 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 .
Important Safety Information
Crestor is contraindicated in patients with a known hypersensitivity to any component of the product and in patients with active liver disease or unexplained persistent elevations of hepatic transaminase, in women who are pregnant or may become pregnant, and in nursing mothers. Cases of myopathy and rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with drugs in this class, including Crestor. These risks can occur at any dose level but are increased at the highest dose (40 mg). The risk of myopathy during treatment with Crestor may be increased with concurrent administration of some other lipid-lowering therapies (fibrates or niacin), gemfibrozil, cyclosporine, or lopinavir/ritonavir. Combination therapy with rosuvastatin and gemfibrozil should be avoided. Crestor should be prescribed with caution in patients with predisposing factors for myopathy, such as renal impairment, advanced age, and inadequately treated hypothyroidism. Patients should be advised to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. It is recommended that liver function tests be performed before and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically (e.g., semiannually) thereafter. Crestor is generally well-tolerated. The most frequent adverse reactions thought to be related to Crestor were headache (3.7%), myalgia (3.1%), abdominal pain (2.6%), asthenia (2.5%), and nausea (2.2%).
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.
In the United States, AstraZeneca is a $12.44 billion healthcare business with more than 12,000 employees. For nearly three decades, AstraZeneca has offered drug assistance programs side by side with its medicines, and over the past five years, has provided over $3 billion in savings to more than 1 million patients throughout the U.S. and Puerto Rico. AstraZeneca has been named one of the "100 Best Companies for Working Mothers" by Working Mother magazine and is the only large pharmaceutical company named to FORTUNE magazine's 2007 list of "100 Best Companies to Work For." In 2006, for the fifth consecutive year, Science magazine named AstraZeneca a "Top Employer" on its ranking of the world's most respected biopharmaceutical employers.
For more information about AstraZeneca, please visit: www.astrazeneca-us.com
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Posted: November 2007
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