FDA probes PCSK9 inhibitors for adverse effects

The FDA has asked Sanofi and Regeneron to investigate an experimental class known as PCSK9 inhibitors designed to block a protein that maintains "bad" LDL cholesterol in the bloodstream. The FDA is "aware of concerns raised with neurocognitive adverse events and other lipid-lowering therapies, including statins, and as part of our oversight of new drug development, we are carefully monitoring these events." Sanofi and Regeneron are not aware of any such effects in trials of SAR 236553 (alirocumab), for Dyslipidaemia.