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FDA approves breakthrough cholesterol drug for high-risk patients (w/video)

 
Published July 24, 2015

The Food and Drug Administration on Friday approved a first-of-a-kind drug that lowers artery-clogging cholesterol more than older drugs that have been prescribed for decades.

The drug from Sanofi and Regeneron Pharmaceuticals offers an important new option for millions of patients at high risk of heart disease. But the drug's sky-high price tag — $14,600 per year — is certain to escalate debate about the cost of breakthrough drugs and who should take them.

The drug, Praluent, is the first in a new class of biotech medications that block a substance that hinders the liver's ability to remove bad, or LDL, cholesterol. The drugs are considered the first major advance in treatment since the introduction of statin drugs more than 20 years ago.

But the prospect of introducing highly expensive, injectable drugs for one of the most common medical conditions is drawing concerns from health insurers, doctors and employers, especially since generic statin pills are available for as little as a dime a day.

More than 73 million U.S. adults, or nearly one-third, have high LDL cholesterol, according to the Centers for Disease Control and Prevention. Those patients have twice the risk of heart disease, the leading cause of death worldwide.

The FDA approved Praluent for two groups of patients at highest risk of heart problems:

• Patients with abnormally high LDL cholesterol caused by an inherited condition.

• Patients with high LDL cholesterol and a history of heart attack, stroke, chest pain and related conditions.

Sanofi estimates those groups account for 8 to 10 million patients in the United States.

In an interview Friday, Sanofi executive Dr. Jay Edelberg said the $14,600-a-year price reflects the "value to the health care system and the value to individual patients." He said costs for a patient who has suffered a heart attack or similar cardiovascular problem range from $50,000 to $119,000 over one year.

But experts say more data is needed to establish if Praluent's cholesterol-lowering ability actually translates into fewer heart problems and deaths.