A new cholesterol drug, released by Isis Pharmaceutical, is a few steps away from being FDA approved. The medicine, which sells under the trade name Kynamro, demonstrated its efficacy in front of the U.S. Endocrinologic and Metabolic Drugs Advisory Committee.
An U.S. Food and Drug Administration Committee recently Okayed Kynamro, a medicine based on mipomersen sodium, created by Isis Pharmaceuticals for the treatment of Homozygous Familial Hypercholesterolemia (HoFH).
After a careful evaluation, the U.S. Endocrinologic and Metabolic Drugs Advisory Committee voted 9 to 6 that Kynamro has “sufficient” efficacy in the treatment of HoFH. The next step for the approval of the drug is an FDA review. Although the Committee’s vote is positive, it will not be the only aspect taken into consideration when approving Kynamro.
Homozygous Familial Hypercholesterolemia is a rare genetic disorder, characterized by the accumulation of low-density lipoprotein (LDL-C), better known as “bad cholesterol”, in the blood. The deposits make the quantity of LDL-C in the body of the patients three to six times higher than in healthy people. The disease affects children and adults and, if left untreated, it leads to heart attack or stroke.
At the moment, HoFH is treated by a change in the patient’s eating habits and lipid-lowering therapies which haven’t managed to prove a satisfying effectiveness so far.