FDA panel backs Amgen cholesterol drug for some patients
WASHINGTON - Federal health advisers say a highly-anticipated cholesterol-lowering drug from Amgen Inc. should be approved for some patients with dangerously high levels of the artery-clogging substance.
The panel of advisers to the Food and Drug Administration voted 11-4 that Amgen's injectable drug Repatha appears safe and effective for some patients with bad cholesterol, including those with an inherited cholesterol disorder. Panelists are set to discuss specifics of who would benefit from the drug.
Panelists voted to endorse the drug despite pending data on whether the drug ultimately reduces heart attacks. Results from an Amgen study on that question aren't expected until 2017.
Repatha is part of a new class of biotech drugs that lower cholesterol more than older statin medications, which have been the standard treatment for more than 20 years.