A new type of cholesterol buster has been recommended for FDA approval by an FDA advisory panel
These drugs, alirocumab and evolocumab, could be more effective than statins
The drugs could be an important alternative for people who do not respond to statins
A Food and Drug Administration advisory committee this week recommended approval of two experimental new cholesterol-fighting drugs that could be more potent and carry fewer side effects than statins, which are among the most prescribed drugs in the United States.
The agency will likely follow the advisory committee’s advice when it decides whether to approve the drugs, alirocumab (Praluent) from Sanofi SA and Regeneron Pharmaceuticals Inc., and evolocumab (Repatha) from Amgen Inc., for patients later this summer.
The drugs represent the most important new class of cholesterol-lowering medications since the first statin was approved in 1987. Seven statins are available in the United States, including Zocor, Lipitor and Crestor.
The new drugs are a “powerful new way of lowering the bad form of cholesterol, and that has profound implications in dealing with the burden of vascular disease,” which can lead to heart attacks and stroke, said Dr. Elliott Antman, president of the American Heart Association.
Although statins will continue to be a mainstay for the management of high levels of bad (LDL) cholesterol and reducing risk of heart attack and stroke, Antman said there are two groups of patients who could strongly benefit from having an alternative to statins.
One is the group that experiences severe side effects to statins, and as a result may stop taking them. The most common side effect is muscle pain and weakness, which is estimated to affect between 10% and 25% of users. In contrast, clinical trials of alirocumab and evolocumab did not find an increase in muscle pain among study participants taking these drugs for several months compared with those taking a placebo control.