FDA approves use of Crestor for children

WILMINGTON, Del. The Food and Drug Administration has approved an anti-lipid drug for use in children with a genetic cholesterol disorder.

AstraZeneca announced Friday the FDA’s approval of Crestor (rosuvastatin calcium) in children ages 10 to 17 with heterozygous familial hypercholesterolemia, a genetic disorder that causes high levels of “bad” LDL cholesterol in the blood and increased risk of early cardiovascular disease, when diet therapy has failed.

The drug is already approved for treating high cholesterol in adults, though AstraZeneca conducted a further study of the drug on children with HeFH.

“AstraZeneca is committed to studying the impact of Crestor in various populations with high unmet medical need, including pediatric and adolescent patients,” AstraZeneca executive director clinical development for Crestor Alex Gold said in a statement.

Based on the company’s submission of an approval application for the new use of the drug, the FDA has extended Crestor’s market exclusivity by six months, to July 2016, AstraZeneca said.