The FDA (U.S. Food and Drug Administration) recently requested that French multinational pharmaceutical company Sanofi SA and the New York-based Regeneron Pharmaceuticals Inc evaluate any “potential neurocognitive side effects” of their experimental, relatively new cholesterol drug alirocumab. They are also in touch with the California-based Amgen Inc another company developing a similar drug. The drugs in question are said to be “part of an experimental class” called PCSK9 inhibitors which were created to stop a specific protein that perpetuates “bad” LDL cholesterol in one’s bloodstream.
FDA representatives would not comment on specific programs but the agency is reportedly “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.”
Both of alirocumab’s co-developers–Regeneron and Sanofi–are unaware of any issues with the new drug are unaware of how the Food and Drug Administration discovered the possibility of any potential side effects of alirocumab. Len Schleifer, CEO of Regeneron told Bloomberg Businessweek: “To date we haven’t seen this problem but we’re going to look for it carefully. Right now this shouldn’t change anything.”
Amgen stated in a press release that they plan on filing for regulatory approval of their PCSK9 drug evolocumab before the year’s end. They have already been watching for potential cognitive impact in their company tests. They state that they have “been in communication with the FDA and (they) will continue to investigate the potential for cognitive impairment.”
New York-based Pfizer Inc, the world’s largest research-based pharmaceutical company, reported that they are also at work developing a PCSK9 drug. Although they have not as of yet been contacted by the FDA, they are already in the process of assessing any potential neurocognitive side effects in their late-stage trials of its drug, bococizumab. “At this stage of our bococizumab development program, we are not aware of any neurocognitive safety signals” they reported.
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