The Food and Drug Administration (FDA) has approved Livalo (pitavastatin; Kowa Pharmaceuticals America, Inc.) for use in pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (ApoB).

The approval was based on a double blind, placebo controlled, 12-week trial in 82 pediatric patients (8-16 years old) with HeFH, fasting LDL-C ≥190mg/dL or LDL-C ≥160mg/dL with an additional cardiovascular risk factor, as well as a 52-week open-label trial in 85 pediatric patients with HeFH. Patients were randomized to receive either placebo, Livalo 1mg, 2mg, or 4mg.

In the 12-week trial, results showed significant dose-dependent reductions in plasma LDL-C, non-high-density lipoprotein (HDL)-C, TC and ApoB in Livalo-treated patients compared with placebo. However, there were no statistically significant improvements in HDL-C or triglycerides (TG) at any Livalo dose. The most common adverse reactions were myalgia, back pain, diarrhea, constipation and pain in extremity, similar to that observed in adults.

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“With the new pediatric indication for pitavastatin, we are pleased to be able to support a broader population of people affected by high cholesterol, which represents an ongoing public health issue,” said Ben Stakely, Chairman, CEO and President of Kowa Pharmaceuticals America, Inc

In addition, Livalo is indicated as adjunctive therapy to diet in adult patients with primary hyperlipidemia or mixed dyslipidemia to reduce elevated TC, LDL-C, ApoB and TG and to increase HDL-C.

Livalo is supplied as 1mg, 2mg, and 4mg strength tablets.

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