The U.S. Food and Drug Administration has approved the cholesterol-lowering drug Repatha that could reduce heart disease and stroke as well as create a financial windfall for biotech giant Amgen Inc.
Repatha (evolocumab) is the second in a new class of cholesterol-lowering injectable drugs given FDA approval that work differently from current statin drugs.
Repatha and the previously approved Praluent from Regeneron Pharmaceuticals Inc. and Sanofi SA, are known as PCSK9 inhibitors.
They work by suppressing genes that slow down the production of cholesterol receptors in the liver, resulting in more receptors available to grab onto "bad" LDL cholesterol, lowering its levels in the bloodstream.
The FDA has approved Repatha for people with hereditary forms of high cholesterol or a high risk of cardiovascular disease whose LDL cholesterol can't be controlled with current medications.
"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," says John Jenkins, M.D., director of the FDA's Office of New Drugs, Center for Drug Evaluation and Research. "Cardiovascular disease is a serious threat to the health of Americans, and the FDA is committed to facilitating the development and approval of effective and safe drugs to address this important public health problem."
Amgen says clinical trials suggest Repatha can reduce LDL by 50 percent or more.
Some experts have expressed concern over the predicted cost of the drug – around $14,100 a year – and worry such an expensive drug to treat a medical problem as common as high cholesterol could drive up costs at the nation's health care system copes with increasing numbers of retiring baby boomers.
Almost a third of U.S. adults have high levels of LDL cholesterol, figures from the Centers for Disease Control and Prevention show.
In addition to the drugs from Amgen and Regeneron, Pfizer is reportedly working on its own version of a PCSK9-blocking drug and is currently conducting its own clinical trials.
When the three drugs are on the market they could account for $10 billion in global sales by 2019, analysts estimate.
