Patients with uncontrollably high cholesterol can now receive proper medication, thanks to a cholesterol-lowering drug that could potentially have great benefits to cardiovascular care. The US Food and Drug Administration (FDA) recommended the approval of the drug in June, and finally gave the product the go-ahead on Friday.
THE FDA APPROVED THE PRALUENT INJECTION IN JUNE
The U.S. Food and Drug Administration has approved Praluent injection, which is the first cholesterol-lowering treatment approved in a “new class of drugs known as a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.”
THIS cholesterol-lowering drug CAN COST AROUND $1,200 FOR A MONTH’S SUPPLY
Sanofi and Regeneron announced the availability of the new medication to adult patients next week. The drug will come in two doses in a pre-filled pen, and patients can then administer it on their own, once every two weeks. A month’s supply of this medication will cost roughly $1,200. This cost will definitely depend upon the patients insurance plan.
The cholesterol-lowering drug was described by the American Heart Association president Dr. Elliot Antman as a powerful new way of lowering the bad form of cholesterol. He also added the importance of Praluent in having profound implications on the vascular diseases. This drug also helps the liver more efficiently rid the body of LDL cholesterol. LDL cholesterol, or low density lipoprotein, is considered to be the bad cholesterol because it contributes to the thick hard plaque-like deposit that can clog arteries and make them less flexible. This results in the condition known as atherosclerosis, that if a clot forms, can result in a heart attack or stroke.
THIS IS FOR PATIENTS WITH HEFH, WHICH RESULTS IN HIGH LDL CHOLESTEROL
This medication was approved by the FDA for patients who have heterozygous familial hypercholesterolemia, also known as HeFh. Hefh is an inherited condition that usually results in high levels of LDL cholesterol. It was also approved for patients who have had a stroke or a heart attack.
Researchers who tested Praluent in the Phase 3 ODDYSSEY program, and resulted in consistent results compared with statins and placebo. This program evaluated 150 mg of the drug every two weeks and found a 58 percent reduction of the LDL cholesterol levels in patients around the 24th week. Around 75 mg, Praluent resulted in a 44 percent of LDL cholesterol levels by the 24th week.
Another new cholesterol-lowering drug that serves the same purpose as Praluent, called Repatha, was also approved recommended to the FDA by the same committee. Europe has already approved the drug last week, but is still being considered for approval in the United States by the FDA.
