FDA Requests Sanofi-Regeneron To Assess Cholesterol Drug Risk

The U.S. Food and Drug Administration (FDA) has requested Regeneron Pharmaceuticals and Sanofi to evaluate how their investigational cholesterol drug affects brain function. The request follows the release of new information connecting the new class of medicines to adverse events in patients.

The request centers on investigational PCSk9 inhibitors, which are designed for patients who are intolerant of statins. Sanofi stated, “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.” The FDA also requested the companies to evaluate the feasibility of integrating new tests for assessing potential cognitive effects in at least a subset of patients involved in their late-stage trials.

The companies’ experimental therapy may hit peak sales of $2.5 billion according to Deutsche Bank analyst Robyn Karnauskas. Pharma companies currently in late-stage testing of the PCSK9 inhibitor therapies include Amgen together with Sanofi and Regeneron. Pfizer, Roche, Merck, and Eli Lilly also have PCSK9 inhibitors under development.

Pfizer has previously released an advisory with its cholesterol-lowering statin Lipitor stating that all statins are associated with rare reports of cognitive impairment including amnesia, memory loss, and confusion. The company said the side effects are not serious in general and reversible upon discontinuation of the drug. Victoria Davis, a spokeswoman for New York-based Pfizer, told Bloomberg, “At this stage of our bococizumab development program, we are not aware of any neurocognitive safety signals. We are monitoring the safety of our patients as we as do for all of our Phase 3 programs.”

Available cholesterol lowering drugs already have warnings about cognitive impairment. Regeneron Chief Executive Officer Len Schleifer told Bloomberg, “To date we haven’t seen this problem but we’re going to look for it carefully. Right now this shouldn’t change anything,” in regard to the timing of the ongoing trials. Regeneron noted the regulatory request in a filing last month.