The US Food and Drug Administration (FDA) has approved AstraZeneca’s Crestor, a treatment for high cholesterol in paediatric patients aged ten to 17.
The treatment is approved for use in young patients with heterozygous familial hypercholesterolemia (HeFH), a genetic disease that causes increased risk of early cardiovascular disease when diet therapy fails to reduce elevated cholesterol.
AstraZeneca US MD Alex Gold said that information about the effects of Crestor in paediatric 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,” Gold said.
The FDA decision was based on a supplemental New Drug Application submitted by AstraZeneca thay included data from the Pediatric Lipid-redUction Trial of rOsuvastatin (PLUTO) study.
In July, the FDA granted AstraZeneca an additional six-month period of exclusivity to market Crestor for its approved cholesterol and atherosclerosis indications until July 2016.
As an adjunct to diet in adult patients, Crestor has been shown to significantly lower LDL-C, a bad form of cholesterol, and has received regulatory approval in over 95 countries to date.