FDA Approves AstraZeneca's Crestor

Published: 16-Oct-2009

For use in pediatric patients with heterozygous familial hypercholesterolemia

The FDA has approved AstraZeneca's Crestor (rosuvastatin calcium) for use in children between 10-17 ages with heterozygous familial hypercholesterolemia (HeFH) when diet therapy fails to reduce elevated cholesterol.

Reportedly, the FDA decision was based on a supplemental New Drug Appliication 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.

In July, AstraZeneca had announced that 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.

Alex Gold, executive director of clinical development for Crestor at AstraZeneca, said: “AstraZeneca is committed to studying the impact of Crestor in various populations with a high unmet medical need, including pediatric and adolescent patients. Information about the effects of Crestor in patients with HeFH will now be included in the Crestor Prescribing Information. While we believe it was important to investigate the use of Crestor in these patients, AstraZeneca does not plan to actively promote this indication.”

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