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FDA Panel Backs First-In-Class Cholesterol Drug06:03


Update, 6/11/2015: On Wednesday, the Food and Drug Administration advisory committee has recommended the agency approve Amgen's Repatha, as well as Sanofi and Regeneron's Praluent. 

Correction: In the audio of our interview about the new cholesterol drugs, from  pharmaceutical companies Sanofi and Regeneron, and Amgen, Professor David Gortler told Here & Now co-host Robin Young indications that new drugs are "going to be a once a week injected product." An Amgen representative contacted us with the following note: "Amgen’s Repatha can be administered every other week or once monthly, not once a week."

Federal health advisers on Tuesday recommended approval for a highly anticipated cholesterol drug from Sanofi and Regeneron Pharmaceuticals, but with the caveat that more data is needed about its long-term ability to reduce heart attacks.

The expert panel recommended by a 13-3 vote that the Food and Drug Administration approve the injectable drug, called Praluent.

But in an unexpected development, a number of panelists said the drug should only be used in patients with abnormally high cholesterol levels caused by an inherited disorder. Those panelists said they wanted to see more data about whether the drug ultimately reduces heart problems, before it is used more broadly.

"I personally fall on the side of having optimism, but I need to see the cardiovascular outcome study to know," said Dr. Philip Sanger of Stanford University, who voted for the drug.

If the FDA follows the group's recommendation, the drug could be approved for a much smaller population than its developers have proposed.

Praluent is part of a new class of injectable drugs that lower cholesterol more than older medications called statins, which have been the standard treatment for more than 20 years. A similar drug from Amgen will go before the same panel on Wednesday.

Both drugs block a substance called PCSK9, which interferes with the liver's ability to remove cholesterol from the blood. Analysts expect the drugs to grow into blockbuster sellers, generating billions of dollars in new sales. But Tuesday's meeting underscores the uncertainty about who should receive such medications.

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 in the U.S.


  • David Gortler, professor of pharmacology at Georgetown University and Yale. He's also a former FDA medical officer and statins expert.
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