Kynamro (mipomersen sodium) injection has just been approved by the FDA 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) to reduce LDL-C, total cholesterol, apolipoprotein B, and non HDL-C in patients with HoFH.
“Kynamro, an injection given once a week, works with other lipid-lowering medications and diet to impair the creation of the lipid particles that ultimately give rise to LDL-C,” said Eric Colman, M.D., deputy director of the Division of Metabolism and Endocrinology Products at the FDA’s Center for Drug Evaluation and Research.
The safety and effectiveness of Kynamro were evaluated in a clinical trial of 51 patients with HoFH. On average, levels of LDL-C fell by about 25 percent during the first 26 weeks in those receiving the drug. Kynamro carries a Boxed Warning on the serious risk of liver toxicity because it is associated with liver enzyme abnormalities and accumulation of fat in the liver, which could lead to progressive liver disease with chronic use.
The most common adverse reactions in the clinical trial included injection site reactions, flu-like symptoms, nausea, headache and elevations in liver enzymes (serum transaminases).
Editor’s Note: While most people are well aware that high cholesterol (fatty deposit) levels in the bloodstream can lead to a build up of artery clogging plaque that can lead to heart disease, as well as the formation of gallstones as well as cancer causing polyps in the colon and even sexual impotence, they don’t always understand what normal cholesterol levels should be.
According to national standards here in the United States, normal cholesterol levels for adults combining both high density lipotproteins (HDL) “good” cholesterol manufactured naturally by our bodies and low density lipoproteins (LDL) “bad”cholesterol obtained by eating food animal products such as meat milk, cheese and eggs, etc., should total 200 mg/dl ( 45-50 HDL and 150 LDL for adult men and 50-60 HDL plus around 140 LDL for women) or lower. Readings of 200-239mg/dl is considered borderline safe, and total levels over 240 is considered high risk for heart disease.