The FDA signaled its support for the approval of two new drugs that would supposedly cut the risk of heart disease from LDL, or "bad" cholesterol.
This Wednesday, an advisory panel at the Food and Drug Administration recommended that agency officials approve Repatha, a drug manufactured by Amgen Inc. that is said to significantly lower low-density lipoprotein cholesterol, what doctors consider to be “bad” cholesterol. According to the Wall Street Journal, the drug could potentially change medical practices and generate billions in sales.
The advisory committee at the FDA voted 11-4 in favor of recommending the approval of Repatha. Though the panel was considering the results of studies that had been carried out over just a 12-week period, they decisively stated that the benefits of the drug outweighed the risks.
The panel additionally voted 15-0 in favor of approving Repatha’s use to treat a rare genetic condition called hypercholesterolemia, which results in abnormally elevated levels of LDL cholesterol. The disorder affects only one in 1 million people, and would be treated with monthly or bi-monthly injections of Repatha.
The same panel voted to approve a similar drug called Praluent earlier this week. The committee expressed concerns that studies examining the two drugs only sought to find how well the drugs lowered LDL levels, and not their efficacy at preventing heart attacks and strokes overall.
According to the FDA, “Reduction of LDL cholesterol alone has been viewed favorably as a surrogate outcome if the reduction was sufficiently robust.” There have certainly not been any safety concerns with lower LDL cholesterol levels, but there have been studies in recent years that question the link between lower LDL levels and reductions in heart disease.
Amgen has commissioned a study of 27,500 participants to further investigate whether or not Repatha lowers the rate of heart attacks and other cardiovascular diseases compared to statins, the current most popular class of drugs used to treat cholesterol. The company said the results would be made available by 2017.