The U.S. Food and Drug Administration approved Thursday the use of evolocumab as an injection treatment that lowers low-density lipoprotein (LDL) cholesterol. Evolocumab, to be known commercially as Repatha, is the second PCSK9 inhibitor drug approved in the U.S.
PCSK9 inhibitors are injectable drugs that lower low-density lipoprotein (LDL) and keep it in control. Repatha is meant to treat patients whose LDL cannot be lowered by their present medication. It is to be used for adult patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia or cardiovascular disease, the FDA said in a press release.
"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 Dr. John Jenkins, director of the Office of New Drugs, Center for Drug Evaluation and Research at the FDA.
Repatha, which is manufactured by Amgen, will be available on the market next week. It is to be administered every other week for a 140 mg injection, a treatment that may may cost up to $14,100 a year. A monthly dosing option of 420 mg injection will be made available on 2016, according to Reuters.
The new LDL lowering drug has relatively few side effects, including upper respiratory tract infection, nasopharyngitis, back pain and flu, and possible reactions like redness or bruising at the injection site.
It is not yet known whether Repatha will also lower the incidence of heart attack and stroke. However, many cardiologists believe that a lower level of LDL will also lower the risk for heart attack and stroke.
"I believe lower is better and do not believe that a very low LDL is harmful," Dr. Daniel Rader, a cardiologist at the University of Pennsylvania, told The New York Times.
