Tags: Sanofi | Regeneron | cholesterol | drug

Sanofi, Regeneron Must Assess Brain Risk in New Cholesterol Drug

Friday, 07 Mar 2014 02:48 PM

Sanofi and Regeneron Pharmaceuticals Inc. must assess the effect of their experimental cholesterol drug on brain function after U.S. regulators learned of adverse events associated with this new class of medicines.

The companies don’t know how the Food and Drug Administration learned of the side effects, Paris-based Sanofi said today in a regulatory filing. Sanofi, Regeneron and Amgen Inc. are among companies in late-stage testing of the anti-cholesterol therapies, known as PCSK9 inhibitors. The PCSK9 protein is associated with high levels of LDL, or “bad” cholesterol.

Pfizer Inc., Roche Holding AG, Alnylam Pharmaceuticals Inc. and Eli Lilly & Co. also have PCSK9 inhibitors under development. Neither Sanofi nor Tarrytown, New York-based Regeneron are aware of any neurocognitive side effects with their drug alirocumab, according to the filing. Amgen, based in Thousand Oaks, California, is the furthest along in development, completing a fifth late-stage study in January.

“The FDA has requested that Sanofi and Regeneron make an assessment of potential neurocognitive adverse events across the global development program for alirocumab, especially in the longer-term studies,” Sanofi said.

Regulators also asked the companies to assess the feasibility of incorporating new tests for the potential cognitive effects “into at least a subset of patients” in their late-stage trials of the experimental drug.

The PCSK9 inhibitors are designed to help people who can’t tolerate statins or can’t get their cholesterol under control with other therapies.

Regeneron fell 7.2 percent to $314.04 at 2:01 p.m. New York time, after declining as much as 10 percent in the largest intraday drop since June 2012. Amgen decreased 1.2 percent to $122.73.

Spokesmen for Regeneron and Amgen weren’t available to comment on the filing.

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Sanofi and Regeneron Pharmaceuticals Inc. must assess the effect of their experimental cholesterol drug on brain function after U.S. regulators learned of adverse events associated with this new class of medicines.
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2014-48-07
Friday, 07 Mar 2014 02:48 PM
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