The Motley Fool: FDA Cholesterol Drug Concerns: What You Should Know

As Sanofi (NYSE: SNY  ) / Regeneron (NASDAQ: REGN  ) , Pfizer (NYSE: PFE  ) , and Amgen (NASDAQ: AMGN  ) prepare for the stretch run to getting their PCSK9 inhibitors, high-potential new treatments for cholesterol, approved by the FDA, a new potential complication has emerged. Sanofi and Regeneron revealed through SEC filings that the FDA is now taking a closer look at potential neurocognitive issues with the entire PCSK9 inhibitor class.

The odds still seem to favor the thesis that PCSK9 inhibitors are safe enough for FDA approval. That said, the role of cholesterol in neurocognitive process is significant, so it's not a ridiculous notion to investigate – particularly considering the possibility that many millions of people will be taking these drugs once they are approved and available.

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FDA Cholesterol Drug Concerns: What You Should Know