|
 Amgen Inc, which is developing a similar drug, said
it has also been in communication with the agency.
The FDA said it could not discuss specific development programs, but
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."
The new drugs are part of an experimental class known as PCSK9
inhibitors designed to block a protein that maintains "bad" LDL
cholesterol in the bloodstream.
"We have not seen a neurocognitive adverse signal in the alirocumab
data," Dr. Michael Aberman, Regeneron's vice president for strategy
and investor relations, said in a telephone interview.
He said the alirocumab trials have been overseen by independent
safety monitors.
"What the FDA asked us to do we don't expect to be difficult or time
consuming," Aberman added.
Sanofi and Regeneron 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.
Pfizer Inc, also in the late stages of developing a PCSK9 drug, said
in an emailed statement that it has not received a similar request
from the FDA but is already assessing potential neurocognitive side
effects in late-stage trials of its drug, bococizumab. "At this
stage of our bococizumab development program, we are not aware of
any neurocognitive safety signals," the company said.
Amgen, which has said it could file for regulatory approval of PCSK9
drug evolocumab this year, said it has been proactively monitoring
for cognitive impairment in its trials.
"Similar to other companies developing PCSK9 inhibitors, Amgen has
been in communication with the FDA, and we will continue to
investigate the potential for cognitive impairment in our program,"
Amgen said in an emailed statement. The company said it has not seen any such signal so far.
[to top of second column] |
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.
Shares of Regeneron fell as much as 10 percent before paring losses
to close down 3 percent, while shares of Amgen dropped 1.5 percent.
U.S.-listed shares of France-based Sanofi fell 1 percent.
Rare side effects such as memory loss, impaired concentration, and
paranoia have been associated with the use of statins for lowering
LDL cholesterol, and their labels include warnings about cognitive
impairment.
Statins, such as AstraZeneca PLC'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 and
stroke.
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.
(Reporting by Deena Beasley; additional
reporting Bill Berkrot; editing by Dan Grebler, Meredith Mazzilli
and Marguerita Choy)
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