FDA Decision On Controversial Experimental Alzheimer's Drug Expected

The US Food and Drug Administration could decide this week whether to grant accelerated approval to the experimental dementia drug lecanemab, according to Eisai and Biogen, the companies that make the drug, Jacqueline Howard reported for CNN.

Photo Insert: Eisai's US headquarters

Lecanemab – one of the first experimental dementia drugs to appear to slow the progression of cognitive decline – has shown “potential” as an Alzheimer’s disease treatment, according to Phase 3 trial results, but raised safety concerns due to its association with certain serious adverse events, including brain swelling and bleeding.

In July, the FDA accepted Eisai’s Biologics License Application for lecanemab under the accelerated approval pathway and granted the drug priority review, according to the company.

The accelerated approval program allows for earlier approval of drugs that treat serious conditions and “fill an unmet medical need” while the drugs continue to be studied in larger and longer trials.

The FDA is expected to decide whether to grant accelerated approval to lecanemab by January 6, Eisai spokesperson Libby Holman confirmed to CNN. “If lecanemab is approved by the FDA under the Accelerated Approval Pathway, Eisai will do its best to make lecanemab available as soon as possible,” Holman wrote in an email.

“Eisai aims to file a Supplemental Biologics License Application for traditional approval in the US soon and to file marketing authorization applications in Japan and Europe by the end of Eisai’s fiscal year 2022, which ends on March 31, 2023.”

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