The U.S. Food and Drug Administration today approved Kynamro (mipomersen sodium) injection 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.
Link this story to your website:
Copy the above code and paste it into your webpage, blog or forum
Be the first one to comment on this news