November 30, 2015
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FDA approves rosuvastatin for use in youth aged 8 to 17 with HeFH

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AstraZeneca announced that the FDA has approved rosuvastatin to reduce total cholesterol, LDL and apolipoprotein B in pediatric patients aged 8 to 17 years with heterozygous familial hypercholesterolemia.

According to the company, rosuvastatin (Crestor, AstraZeneca) can now be administered to that patient population after failure of an adequate-length attempt at control through diet if LDL > 190 mg/dL or if LDL > 160 mg/dL and the patient has a family history of CVD or at least two other risk factors for CVD.

The age range for rosuvastatin in this population has been extended, as the drug had already been approved for patients aged 10 to 17 years with HeFH, according to the company.

According to United States and European guidelines, statins are the first line of medical therapy for HeFH, which affects approximately one in 500 people.