FDA panel seeks approval for more effective cholesterol drug

An FDA advisory committee consisting of 15 experts has voted that the new and highly powerful cholesterol shot Repatha should be approved. Repatha is a medicine manufactured and marketed by biotech giant Amgen.

In addition to Repatha (evolocumab) by Amgen Inc. the FDA wants another cholesterol lowering drug to be approved; it’s Praluent (alirocumab) by Sanofi SA & Regeneron Pharmaceuticals Inc. The agency will most likely abide by the committee’s advice when they will be deciding whether to approve these cholesterol drugs for patients.

The drugs recommended by the FDA panel of 15 might be more powerful and carry much less side effects compared to statins, the most widely used cholesterol lowering medications. They represent the most vital new class of cholesterol drugs since the approval of the first statin way back in 1987. Right now, a total of seven statins including Crestor, Lipitor and Zocor are available in the US.


According to the president of the American Heart Association Dr. Elliott Antman, the new cholesterol medications backed by the FDA panel mark a more powerful way of lowering bad cholesterol. He added that the drugs possess greater ability of dealing with the burden imposed by vascular disease, condition that can result in strokes and heart attacks.

Antman added that although stains will still be a mainstay when it comes to managing high level of LDL cholesterol or bad cholesterol and minimizing risk of stroke and heart attack, there are two categories of patients who will be benefited hugely by the availability of a statin alternative.


The first category will be of patients who experience severe side effects of statins, which often ends up forcing them to stop use of the drug. Two of the most common side effects of the drug are weakness and muscle pain; these side effects are known to affect 10-25% patients treated with statins. Clinical trials of evolocumab and alirocumab revealed that patients treated with these drugs for several months don’t experience side effects like muscle pain.

The other category of patients to be benefited would be individuals whose LDL cholesterol level keeps on hovering above the desired level even after being treated with statins. Antman said that this problem is comparatively rare and is observed in 1 out of 500 patients with high level of cholesterol; they experience the problem as a result of having a genetic predisposition that might have an impact on their reaction to statins.