FDA Panel Backs First-in-Class Cholesterol Drug
Tuesday, June 9, 2015
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.