FDA probes cognitive impact of new cholesterol drugs

By Reuters Staff

The U.S. Food and Drug Administration has called for an assessment of potential neurocognitive side effects of an experimental cholesterol drug being developed by Regeneron and Sanofi, Sanofi said on Friday.

Sanofi said it had been advised by the FDA that the agency had become aware of neurocognitive adverse events associated with an experimental class of drugs known as PCSK9 inhibitors.

PCSK9 inhibitors are antibodies designed to block proprotein convertase subtilisin/kexin type 9, a protein whose natural function is to maintain the presence of LDL cholesterol in the bloodstream.

Regeneron and Sanofi are conducting pivotal-stage trials of the PCSK9 inhibitor alirocumab.

The companies said they were not aware of any neurocognitive adverse event signal relating to alirocumab.

They also said neurocognitive issues have been associated with the use of statins for lowering LDL cholesterol.

Both Pfizer and Amgen are also in the late stages of developing PCSK9 inhibitors.

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