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FDA panel votes on alternative to statins

The first new approach to fighting cholesterol in three decades could move closer to reality Tuesday
Combating cholesterol: FDA eyes injections as statin alternative 03:09

Statins have been the drug of choice for cholesterol-lowering medication for the past thirty years. That might change in the next few months.

An FDA advisory panel has voted to recommend approval of two new injectable cholesterol-lowering drugs that work differently than older, statin drugs to lower "bad" cholesterol, or low-density lipoprotein (LDL).

The two drugs, Praluent by drug company Sanofi and Repatha from Amgen, are a class of drugs known as PCSK9 inhibitors. These drugs block the PCSK9 protein in the blood, which allows the body to more effectively clear LDL cholesterol. The panel voted Tuesday to recommend approval of Praluent; the vote for Repatha came on Wednesday.

"While statins can lower cholesterol 30 to 40 percent, these drugs can lower it about 60 to 70 percent," Dr. Tara Narula, a cardiologist at Lenox Hill Hospital in New York, told "CBS This Morning."

Narula said that at this point she does not see PCSK9 as replacing statins altogether, because statins are "generic and affordable, relatively well tolerated and tested in terms of showing us reduced events of cardiovascular disease over time."

This new class of drugs is specifically going to be targeted for three groups:

  • Patients who are intolerant to statins
  • Those who produce a lot of cholesterol and don't respond as well to statins (a problem that affects 1 in every 250 to 500 Americans)
  • High-risk patients who have had a heart attack or stroke, are on high doses of statins and can't get their cholesterol low enough
Are statins enabling an unhealthy lifestyle? 02:18

The FDA is weighing whether or not to approve the drug based on its efficacy at lowering cholesterol, or to wait for long-term study results. A decision could come in July or August if the current data is considered sufficient.

Side effects of PCSK9's are minimal and include injection site reactions, flu-like symptoms, and memory impairment, which is also being studied in statin use. A study released on Monday found no link between statins and memory loss, although patients may be more likely to report memory issues when they first start taking the drugs.

Health insurance providers and payers have voiced concern about the prospect of approving the new class of drugs because the injectables, which would be taken once every two weeks or once a month, are expensive and cannot be made in generic form.

"Statins, especially when they're generic can go for about $4 a month, this drug can be anywhere from $500 to $1,000 a month." Narula said. "And we're not likely to see a generic version because this is a biologic drug, it's an antibody, it's not a chemical drug."

Ongoing trials on Praluent and Repatha will wrap up in 2017 and 2018 to further study side effects and to see whether drugs also reduce heart attacks, strokes and deaths over time.

Nearly 1 in 3 American adults lives with elevated LDL and fewer than half are being treated for the condition, which is a major risk factor for heart disease.

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