The Food and Drug Administration (FDA) is asking pharmaceutical companies to assess potential neurocognitive side effects associated with experimental cholesterol-lowering drugs from a new class of medications they are developing. The agency said it is “aware of concerns raised with neurocognitive adverse events and other lipid-lowering therapies, including statins,” and as part of its oversight the agency said it was carefully monitoring these types of events.
The drugs are from a new class of cholesterol-lowering medications known as PCSK9 inhibitors that are designed to block a protein that benefits LDL cholesterol – the so-called “bad” cholesterol – in the blood. Regeneron Pharmaceuticals, Sanofi SA, Amgen Inc., and Pfizer currently have PCSK9 inhibitor drugs in development.
Statins, such as Pfizer’s Lipitor, are the most widely prescribed cholesterol-lowering medications. They work by blocking the liver’s production of LDL cholesterol. Statin side effects include memory loss, impaired concentration and paranoia. They have also been linked to muscle injury, liver damage, and type 2 diabetes.
While PCSK9 drugs have yet to be reviewed by the FDA, the drugs hold promise as a safer alternative to statins. Sanofi and Regeneron say they are not aware of any cognitive side effects associated with their PCSK9 drug, alirocumab. Amgen says it has been proactively monitoring for cognitive impairment with its drug, evolocumab. Pfizer says it is already assessing neurocognitive side effects with bococizumab, which is currently in late-stage trials.