GAITHERSBURG, Md. – Federal health advisers are recommending approval for a highly-anticipated cholesterol drug, but with the caveat that more data is needed about its long-term ability to reduce heart attacks.
A panel of experts recommended voted 13-3 to recommend the Food and Drug Administration approve Sanofi and Regeneron Pharmaceutical's injectable drug.
But in a surprising development, a number of panelists said the drug should only be used in patients with abnormally high cholesterol levels caused by an inherited disorder. Before it is used more broadly, most panelists said they wanted to see more data about whether the drug ultimately reduces heart problems.
The drug is part of an experimental class of medicines that lower cholesterol more than statins, the older medications that have been the standard treatment for more than 20 years.