FDA advisers approve new medications to lower cholesterol

Two new cholesterol drugs could soon be on the market.

Late today, advisers to the FDA voted to approve a second medication in a new class of drugs which can dramatically lower cholesterol.

They voted 11 to 4 in favor of approving Repatha, which is made by Amgen.

Yesterday, the panel of experts recommended approval for Praluent, from Sanofi and Regeneron Pharmaceuticals, by a 13-3 margin.

The new drugs aren't in pill form, but are given with an injector pen, like insulin.

They're designed to block a substance called PCSK9, which interferes with the body's ability to remove cholesterol from the blood.

In tests, they dropped the bad cholesterol by 40 to 60 percent.

The FDA advisers did recommended approval. But 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.

And the drugs will not be cheap.

They price is expected to be about $10,000 a year, compared to statins, which cost about $250 a year.

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.

Key to the panel's decision was whether lowering bad, or LDL, cholesterol translates into reduced heart attacks.

For over 20 years, the FDA has used reduced LDL levels as a benchmark to approve cholesterol drugs, including statins like Lipitor and Zocor.

But recent studies of drugs like niacin have shown that reducing cholesterol levels does not always lead to reductions in heart attack, stroke and related problems.

The FDA's internal scientists pressed panelists on whether they thought lower LDL cholesterol was still an accurate predictor of a drug's benefit.

"I don't believe we have enough data today to say that LDL, with a new drug class, is sufficient for approval," said Dr. William Hiatt, of the University of Colorado's School of Medicine, who voted against the drug.

The FDA is scheduled to make its decision July 24. It is not obligated to follow its advisory panel, however, it generally does.