The FDA has approved AstraZeneca’s 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 and increased risk of early cardiovascular disease. The FDA said its decision was based on a supplemental new drug application submitted by the London-based 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, the FDA granted an additional six-month period of exclusivity to market Crestor for its approved cholesterol and atherosclerosis indications until July 2016, according to the pharmaceutical company.