BRIEF—Kowa's Livalo gets pediatric designation from FDA

The US Food and Drug Administration has approved the local subsidiary of Japan’s Kowa Company’s cholesterol-lowering drug Livalo (pitavastatin) for pediatric patients aged eight years and older with heterozygous familial hypercholesterolemia (HeFH) to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (Apo B).

The approval was granted in conjunction with fulfillment of FDA’s Written Request to obtain pediatric information on pitavastatin and provides a six-month pediatric exclusivity with regard to the US patent protection for Livalo.

The pediatric label indication for Livalo is supported by a 12-week, double-blind, placebo-controlled trial in 82 pediatric patients eight to 16 years of age with HeFH, and a 52-week open-label trial in 85 pediatric patients with HeFH.