FDA Panel Gives Thumbs Up to Potentially Revolutionary Cholesterol Drug

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People who have taken the drugs have seen their LDL cholesterol plunge to remarkably low levels, going down by 40 to 65 percent, even if the starting level was achieved with a statin.

A Food and Drug Administration (FDA) committee earlier this week recommended approval of a new biologic drug to lower LDL, so-called “bad” cholesterol and protect against heart attacks. If approved, it would be the first in a major new class of medicines in a generation that significantly lower levels of cholesterol, the leading cause of heart disease.

People who have taken the drugs have seen their LDL cholesterol plunge to remarkably low levels, going down by 40 to 65 percent, even if the starting level was achieved with a statin; and safety studies so far have found the drugs seem to have no more side effects than a placebo. But definitive evidence of the drugs’ effectiveness in reducing heart attacks and deaths will come only after large clinical trials are completed in 2017.

The new drugs are injectable, as opposed to coming in pill form like statins, and are raising hope for patients who cannot get their cholesterol down low enough toward their doctor’s goals or who cannot take statins because they either don’t work for them or carry a side effect of muscle breakdown and pain.

The companies aren’t saying yet what they plan to charge. But Dr. William Shrank, chief scientific officer at CVS Health, estimates they will cost $7,000 to $12,000 a year.

Curated from The New York Times