For nearly a year, my stance on Cassava Sciences and its Alzheimer’s disease drug candidate simufilam has been clear: Emerging evidence shows the drug is inert, and patients with Alzheimer’s were misled into participating in ongoing Phase 3 clinical trials, so therefore, the Food and Drug Administration must take immediate steps to protect these vulnerable people from further harm.
Finally, there is some progress to report. The FDA is aware of the Cassava situation, spokesperson Jeremy Kahn told me, when I asked him what the agency intended to do after the Securities and Exchange Commission last week charged Cassava and two former executives with making misleading claims about simufilam.
“The FDA does not confirm or deny potential or ongoing investigations,” Kahn said, adding, “As a general matter, protecting the rights, safety, and welfare of people who participate in clinical trials is a critical aspect of the FDA’s mission.”
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