Rosuvastatin Cleared for Pediatric FH

October 20, 2009

October 20, 2009 (Wilmington, Delaware) — The Food and Drug Administration (FDA) has approved rosuvastatin (Crestor, AstraZeneca) for use in children aged 10 to 17 years old with familial hypercholesterolemia [1]. The drug is approved for use when diet alone fails to reduce LDL-cholesterol levels.

The approval is based on data from the Pediatric Lipid Reduction Trial of Rosuvastatin (PLUTO), a 12-week randomized, controlled trial that examined the safety and efficacy of rosuvastatin in 177 pediatric familial hypercholesterolemia patients.

As part of the supplemental new drug application, the company showed that treatment with rosuvastatin reduced LDL cholesterol over the 12-week period more than treatment with placebo. Treatment with 5 mg, 10 mg, and 20 mg reduced LDL-cholesterol levels 38.5%, 44.4%, and 50.2%, respectively, compared with no significant change with placebo. The drug was well tolerated, with no evidence of an increased frequency of serious adverse events.

Earlier this month, the FDA approved an expanded indication for colesevelam HCl tablets and a new powder for oral suspension (Welchol, Daiichi Sankyo) as an adjunct to diet and exercise to reduce LDL-cholesterol levels in boys and postmenarchal girls aged 10 to 17 years old with heterozygous familial hypercholesterolemia.

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