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AstraZeneca (AZN) Release: Labeling Revision For CRESTOR(R) Approved By FDA; Warning Issued On Use Of Crestor By Asians


10/19/2005 5:12:54 PM

WILMINGTON, Del., March 2 /PRNewswire-FirstCall/ -- AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) approved revisions to the prescribing information for its cholesterol-lowering medication, CRESTOR(R) (rosuvastatin calcium), based on submissions made by AstraZeneca. The Company is committed to providing the most up-to-date information about the appropriate use of CRESTOR, and will proactively communicate these revisions to healthcare professionals.

"Post-marketing data for CRESTOR has been thoroughly reviewed over the past year and this labeling revision is the result of that analysis," said David Brennan, President and CEO, AstraZeneca U.S. "The revisions that the FDA has approved provide physicians with further clarification on how best to use CRESTOR with their patients. We continue to believe that CRESTOR is safe and effective when used according to the prescribing information."

The basis for the agreed revisions to the prescribing labeling for CRESTOR, which strengthen points contained in the original labeling, include modifications to dosage instruction; recent clinical trial information regarding special populations; and information regarding post-marketing safety experience with the medicine, based upon information from clinical trial and extensive post-marketing data.

CRESTOR is now approved in 70 countries, has been prescribed more than 18 million times for more than 4.3 million patients and has been studied in clinical trials of more than 46,000 patients.

"CRESTOR is highly effective at helping patients to reduce their elevated cholesterol levels, along with diet," said James Blasetto, MD, Executive Director, Strategic Development, CRESTOR. "AstraZeneca is committed to ensuring appropriate usage of CRESTOR, and we are pleased that this labeling revision will help us do just that."

Patient safety is the top priority for AstraZeneca. AstraZeneca will continue to evaluate CRESTOR through clinical trials and ongoing post-marketing surveillance and will continue to provide the FDA with complete, up-to-date information about the safety of CRESTOR.

Highlights of Labeling Revisions

The revisions to the prescribing information for CRESTOR are based on 15 months of post-marketing surveillance and ongoing data analysis. Following is a summary of changes to the warnings, precautions, dosage and administration sections of the label.

The initial labeling for CRESTOR was approved by the FDA based on pre-approval data from clinical trials. New information has been added to the labeling to reflect clinical and post-marketing adverse experiences seen in the 15 months following the approval of CRESTOR. Consistent with other drug labeling in the statin class, irrespective of causality, jaundice has been added as a very rare event. In addition, as with other statins, reports of rhabdomyolysis with CRESTOR are rare, but higher at the highest marketed dose (40mg). The 40mg dose of CRESTOR comprises 4 percent of total sales for CRESTOR in the U.S.

Initial instructions regarding usage of the 40 mg dose were made more explicit by strongly instructing that physicians reserve the 40 mg dose only for those patients who have not achieved their LDL-C or "bad" cholesterol goal utilizing the 20 mg dose of CRESTOR.

The revised labeling includes data from a pharmacokinetic study recently completed in the U.S., involving North-Americans of Asian descent. The results of this study showed higher drug exposure in this specific population relative to Caucasians. The findings from this study are consistent with information included in the original labeling for CRESTOR that was based on a study done outside of the U.S. The revised labeling includes dosing instructions for this population.

About CRESTOR

CRESTOR (rosuvastatin calcium) is a once-daily prescription medication for use as an adjunct to diet in the treatment of various lipid disorders including primary hypercholesterolemia, mixed dyslipidemia and isolated hypertriglyceridemia. It is a member of the statin (HMG-CoA reductase inhibitors) class of drug therapy. 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. However, initiation of therapy with 5 mg once daily should be considered for patients requiring less aggressive LDL-C reductions or who have predisposing factors for myopathy, and for special populations such as patients taking cyclosporine, Asian patients, and patients with severe renal insufficiency. For patients with marked hypercholesterolemia (LDL-C >190 mg/dL) and aggressive lipid targets, a 20-mg starting dose may be considered. AstraZeneca licensed worldwide rights to CRESTOR from the Japanese pharmaceutical company Shionogi & Co., Ltd.

Important Safety Information

CRESTOR is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases, in women who are pregnant or may become pregnant, and in nursing mothers. 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. Rare cases of rhabdomyolysis with acute renal failure secondary to myoglobinuria have been reported with CRESTOR and with other drugs in this class. 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. The benefit of further alterations in lipid levels by the combined use of rosuvastatin with fibrates or niacin should be carefully weighed against the potential risks of this combination. Combination therapy with rosuvastatin and gemfibrozil should generally 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. CRESTOR is generally well-tolerated. Adverse reactions have usually been mild and transient. The most frequent adverse events thought to be related to CRESTOR were myalgia (3.3%), constipation (1.4%), asthenia (1.3%), abdominal pain (1.3%) and nausea (1.3%).

About AstraZeneca

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 over $21.4 billion and leading positions in sales of gastrointestinal, cardiovascular, respiratory, oncology and neuroscience products. In the United States, AstraZeneca is a $9.6 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit: http://www.astrazeneca-us.com/

AstraZeneca

CONTACT: Kellie Caldwell of AstraZeneca LP, +1-302-885-1435,kellie.caldwell@astrazeneca.com, or Steve Lampert of AstraZeneca LP,+1-302-886-7862, steve.lampert@astrazeneca.com


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