AstraZeneca announced the US Food and Drug Administration (FDA) approved CRESTOR (rosuvastatin calcium) for use in children 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 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.
"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," 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.
About Heterozygous Familial Hypercholesterolemia
Heterozygous familial hypercholesterolemia affects 10 million people worldwide and is most commonly caused by a defect in the LDL-C receptor gene that leads to elevated LDL-C levels. The American Academy of Pediatrics states that statin therapy should be considered for children with LDL levels greater than 190 mg/dL.
About PLUTO
The PLUTO (Pediatric Lipid-redUction Trial of rOsuvastatin) study was a 12-week, double-blind, randomized multicenter, placebo-controlled study with a 40-week, open-label follow-up. The PLUTO study was designed to evaluate the efficacy and safety of CRESTOR in children ages 10-17 with heterozygous familial hypercholesterolemia (HeFH), a genetic disease characterized by high LDL cholesterol (the "bad" cholesterol) and early cardiovascular disease.
About CRESTOR (rosuvastatin calcium)
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 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.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com.