Technology | October 16, 2009

FDA Clears CRESTOR for Pediatric Patients With Heterozygous Familial Hypercholesterolemia

October 16, 2009 – AstraZeneca yesterday said the U.S. Food and Drug Administration cleared CRESTOR (rosuvastatin calcium) for use in pediatric patients ages 10-17 with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol.

HeFH, a genetic disease, is characterized by high LDL cholesterol (the "bad" cholesterol) and increased risk of early cardiovascular disease.

The FDA decision was based on a supplemental new drug application submitted by AstraZeneca, which included data from the PLUTO (Pediatric Lipid-redUction Trial of rOsuvastatin) study. PLUTO was designed to evaluate the efficacy and safety of CRESTOR in children ages 10-17 with HeFH. The PLUTO study was a 12-week, double-blind, randomized multicenter, placebo-controlled study with a 40-week, open-label follow-up.

In July, AstraZeneca announced the FDA had granted an additional six-month period of exclusivity to market CRESTOR (rosuvastatin calcium) for its approved cholesterol and atherosclerosis indications until July 2016. The decision was based on the supplemental new drug application submitted by AstraZeneca.

The completion of the PLUTO study satisfied AstraZeneca's commitment to the FDA to conduct a study evaluating the impact of CRESTOR on this pediatric population.

Studies have previously shown that CRESTOR, as an adjunct to diet in adult patients, significantly lowered LDL-C, had a significant effect on raising HDL-C and slowed the progression of atherosclerosis, an underlying cause of cardiovascular disease.

CRESTOR is indicated as an adjunct to diet to reduce elevated Total-C, LDL-C, ApoB, non-HDL-C, and TG levels and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia. CRESTOR is also approved for pediatric patients 10 to 17 years of age with heterozygous familial hypercholesterolemia (HeFH) after failing an adequate trail of diet therapy. 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 is not approved to reduce cardiovascular morbidity and mortality.

CRESTOR has now received regulatory approval in over 95 countries. Nearly 17 million patients have been prescribed CRESTOR worldwide. Data from clinical trials and real world use shows that the safety profile for CRESTOR is in line with other marketed statins.

For more information: www.astrazeneca-us.com

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