The injectable drug, called Praluent and developed by Regeneron Pharmaceuticals Inc. and Sanofi SA, was approved by the Food and Drug Administration (FDA) as the first in a new class of drugs called PCSK9 inhibitors.
The drug is supposed to make the liver work more efficiently at removing LDL-C, or bad cholesterol. LDL-C stands for low-density lipoprotein cholesterol, one of the major building blocks of plaque buildup in arteries.
Praluent is approved for people with heterozygous familial hypercholesterolemia, or HeFh, an inherited condition that causes high LDL cholesterol levels. It is also approved for patients with clinical atherosclerotic cardiovascular disease, such as those who have had a stroke or heart attack.
Dr. Donald A. Smith, an associate professor of medicine and cardiology at Mount Sinai Hospital in New York said, “It focuses on those who’ve truly had clinical disease or those who start out with such high levels of LDL they can’t get anywhere near where they should be and I think those are the most at-risk people.”
The new drug is desperately needed for several million high-risk patients who are unable to get their LDL levels lowered using the group of medicines known as statins. There are currently seven of these medicines on the market. Some patients can’t take statins because of the side-effects produced, or because of familial HeFh.
Regeneron said on Friday the new drug could be ready for release as early as next week, in two doses available in a prefilled pen that patients administer to themselves every two weeks. But now comes the biggest complaint already being voiced about the new medication; its cost.
Both companies are pricing the drug at a wholesale cost of about $1,200 a month, or $14,600 a year to treat a very common condition like high cholesterol or heart disease. This high cost is in comparison to statins, available in brand names for around $500 to $700 a year, or generic versions for about $48 a year.
