March 7 The U.S. Food and Drug Administration
has asked Regeneron and Sanofi to assess
potential neurocognitive side effects of their experimental
cholesterol drug, Sanofi said in its annual report on Friday.
The regulatory filing sent shares of Regeneron down 6
percent in Nasdaq trading. U.S.-listed shares of France-based
Sanofi were down 1 percent.
Their drug, alirocumab, is part of a new class known as
PCSK9 inhibitors designed to block a protein that maintains
"bad" LDL cholesterol in the bloodstream.
Pfizer and Amgen are also in the late
stages of developing PCSK9 drugs.
Pfizer said in an emailed statement that it has not received
a similar request from the FDA. "At this stage of our
bococizumab development program, we are not aware of any
neurocognitive safety signals," the company said.
Officials at Amgen did not immediately respond to a request
Sanofi's report echoed a filing made by Regeneron last
month, in which the company said the FDA advised it was aware of
adverse neurocognitive effects associated with PCSK9 inhibitors.
The FDA and Regeneron did not immediately respond to
requests for comment.
The companies said they did not know how the FDA learned of
the potential side effects, and they were not aware of any such
side effects with alirocumab.
Rare issues such as memory loss, impaired concentration, and
paranoia 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.
"While we continue to believe the PCSK9 class has
multi-billion dollar potential, we note that increased
speculation on adverse events may increase the probability that
the FDA could require outcomes data prior to full approval," JP
Morgan analyst Geoff Meacham said in a research note.
The FDA said last year that PCSK9 drugs could get regulatory
approval based on their ability to lower bad cholesterol, and
may not need to show that they reduce the risk of heart attack
In their filings, Sanofi and Regeneron said that if studies
detect neurocognitive or other adverse side effects, development
of alirocumab could fail or be delayed.