FDA Expands Crestor Use in Pediatric Patients

The approval is indicated for patients aged 7–17 years, as an adjunct to diet
The approval is indicated for patients aged 7–17 years, as an adjunct to diet

The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Crestor (rosuvastatin calcium; AstraZeneca) tablets for use in pediatric patients aged 7–17 years with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total C, nonHDL-C, and ApoB as adjunct to diet, either alone or with other lipid-lowering treatments (eg, LDL apheresis). 

Also, the FDA has expanded the use of Crestor in pediatric patients with heterozygous familial hypercholesterolemia (HeFH) for ages 8–17 years to reduce elevated total-C, LDL-C and ApoB after failing an adequate trial of diet therapy; it was previously indicated for use in patients aged 10–17 years old. The recommended dose range is 5–10mg once daily in patients aged 8–<10 years old, and 5–20mg once daily in patients aged 10–17 year old. For HoFH, the recommended dose is 20mg once daily in patients aged 7–17 years old. 

In addition, Crestor is also indicated as an adjunct to diet in primary hyperlipidemia and mixed dyslipidemia (Types IIa and IIb) to reduce elevated total-C, LDL-C, ApoB, non-HDL-C, and TG, and to increase HDL-C; adjunct to diet in hypertriglyceridemia; adjunct to diet in primary dysbetalipoproteinemia (Type III hyperlipoproteinemia); adjunct to other lipid-lowering treatments (or if these treatments are unavailable), in homozygous familial hypercholesterolemia to reduce LDL-C, total-C, and ApoB; adjunct to diet to slow the progression of atherosclerosis as part of a treatment strategy to lower total-C and LDL-C to target levels; and to reduce risk of MI, stroke, or arterial revascularization procedures in patients without clinically evident CHD but with an increased risk of CVD based on age (men ≥50 years, women ≥60 years), hs-CRP ≥2mg/L, and at least one additional risk factor. 

Crestor, an HMG Co-A reductase inhibitor, works by increasing the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL, and by inhibiting hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.

Crestor is available as 5mg, 10mg, 20mg, and 40mg strength tablets.

For more information call (800) 236-9933 or visit Crestor.com.

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