March 7 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 in its
annual report on Friday.
The regulatory filing sent shares of Regeneron down 8
percent in Nasdaq trading. U.S.-listed shares of France-based
Sanofi were down 1 percent.
The Sanofi statement repeated a filing made by Regeneron
last month, in which the company 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
Regeneron and Sanofi are conducting pivotal-stage trials of
alirocumab, an PCSK9 antibody designed to block a protein whose
natural function is to maintain the presence of "bad" LDL
cholesterol in the bloodstream.
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.
Statins, such as AstraZeneca's Crestor and generic forms of
Pfizer's Lipitor, are the most widely used
cholesterol-lowering treatments and work by blocking the liver's
production of LDL cholesterol.
Both Pfizer and Amgen are also in the late stages
of developing PCSK9 drugs.