Injected cholesterol drug is new option
Residents with high cholesterol have a new choice. On August 27, the U.S. Food and Drug Administration announced approval of a Repatha injection for patients who cannot reduce their low-density lipoprotein cholesterol.
Repatha is part of a new class of drugs called PCSK9 inhibitors. They can be used, in addition to diet and statins, for patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease. It is an antibody targeting a specific protein called PCSK9 that inhibits receptors on the liver to remove LDL cholesterol. As the drug blocks PCSK9, the receptors rebound and lower LDL cholesterol.
“Repatha provides another treatment option in this new class of drugs for patients with familial hypercholesterolemia or with known cardiovascular disease who have not been able to lower their LDL cholesterol enough with statins,” said John Jenkins, M.D., director of the Office of New Drugs, Center for Drug Evaluation and Research.
Patients taking Repatha had an average reduction of LDL cholesterol of around 60% when compared to the placebo group. There is a trial to evaluate whether adding Repatha to statins is effective.
Amgen Inc. markets the drug and said it was to be available in September. In clinical trials, side effects included nasopharyngitis, upper respiratory tract infection, flu and back pain, and reactions such as redness, pain or bruising where the injection is given.
One possible barrier is cost: Repatha is $542.31 for a 140mg single-use dose, which is given every two weeks, Amgen said.
“We will be working with payers and other purchasers to provide innovative pricing programs linking the net price of Repatha to the expected LDL cholesterol reductions and anticipated appropriate patient utilization,” said Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen.
In July, Sanofi and Regeneron's Praluent launched their PCSK9 inhibitor.