On Tuesday, an FDA committee voted to recommend approval for the first new drug in a generation to lower cholesterol.
After a lifetime battling high cholesterol, Peggy O’Connor had a heart attack three years ago at age 56. But she couldn’t tolerate statins to lower her bad cholesterol.
“When I started on the statin I started having muscle spasms and pain,†said O’Connor.
In typical patients, a high dose of statin can lower bad cholesterol up to 50% percent. But there are millions of people with very high cholesterol like O’Connor who can’t tolerate statins, or for whom statins just don’t work.
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A year and a half ago, she enrolled in a clinical trial of a drug called Alirocumab.
The medication is injected twice a month, and it works by blocking the action of a protein, improving the liver’s ability to remove bad cholesterol or LDL from the bloodstream. In clinical trials the drug lowered LDL levels by more than 60%.
A new drug could replace statins for some patients battling high cholesterol levels.
Over the last year and a half, O’Connor’s bad cholesterol has dropped by more than 100 points.
“My highest number was 170,†she said. “My number a few weeks ago was 50.â€
Dr. Steve Nissen of the Cleveland Clinic is testing other drugs in this class. Although the drug has not yet been shown to prevent heart attacks or stroke, he believes it will save lives.
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“If we inhibit that protein for long periods of time getting LDL cholesterol down as low as 30 or 40 that it may well turn cardiovascular disease no longer into the number one killer of men and women,†he said.
The advisory committee will consider a similar drug tomorrow and the FDA could approve them for use later this year.
These drugs are biologics, so they will be much more expensive than statins, costing around $10,000 a year.