FDA approves Kynamro (Genzyme/Sanofi) to treat Homozygous Familial Hypercholesterolemia

The FDA 0n 29 January 2013 approved Kynamro (mipomersen sodium) injection, from Genzyme/Sanofi, as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called Homozygous Familial Hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C).

HoFH, an inherited condition that affects about one out of every one million people in the United States, occurs when the body is unable to remove LDL-C, often called �bad� cholesterol, from the blood causing abnormally high levels of circulating LDL-C. For those with HoFH, heart attacks and death often occur before age 30.

Kynamro is an orphan drug approval, meaning it was developed to treat a disorder affecting fewer than 200,000 people. In December 2012, the FDA approved Juxtapid (lomitapide) from Aegerion Pharma, to reduce LDL-C, total cholesterol, apolipoprotein B, and non HDL-C in patients with HoFH.