AstraZeneca (NYSE: AZN) today announced the U.S. Food and Drug Administration (FDA) approved 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.
"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 pediatric patients with HeFH will now be included in the CRESTOR Prescribing Information," said Alex Gold, MD, Executive Director of Clinical Development for CRESTOR, AstraZeneca US. "While we believe it was important to investigate the use of CRESTOR in these patients, AstraZeneca does not plan to actively promote this indication."
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.