A federal advisory committee this week will decide whether to recommend approval of the first in a new class of drugs many experts believe could significantly cut the risk of strokes and heart attacks, a leading cause of death for Americans.

The highly anticipated new drugs have been shown in clinical trials to sharply reduce levels of bad, or LDL cholesterol, representing the first major advance in the area since widely used statin drugs hit the market in the late 1980s.

“This is one of the biggest developments in a long time in cardiology,” said Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, who is involved in clinical trials for two of the new treatments under development. “The effects of these drugs are very robust.”

Millions of Americans each year currently take statin drugs intended to lower levels of bad cholesterol, which can greatly increase the risk of heart disease. According to the Centers for Disease Control and Prevention, more than 73 million Americans – nearly a third of all U.S. adults – suffer from high LDL cholesterol.

But there are some patients who can’t tolerate statins, and many still can’t get their bad cholesterol levels low enough. That’s where the new class of cholesterol-busting drugs being considered by the Food and Drug Administration comes in.

Studies published this spring in the New England Journal of Medicine showed that two PCSK9 drugs currently under development – one by Amgen and another by Sanofi and Regeneron Pharmaceuticals – reduced bad cholesterol by roughly 60 percent.


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