Medical Advocate Urges FDA Against Perceived “Done Deal” Approval of Lecanemab

WASHINGTON, D.C. – Public Citizen today urged the U.S. Food and Drug Administration (FDA) against approval this week of lecanemab, developed by Eisai Co. and Biogen Inc. for the treatment of Alzheimer’s disease, as a deadline for the drug’s approval approaches this Friday.

In a letter sent today by Public Citizen’s Health Research Group, senior advisor Dr. Sidney Wolfe urged FDA commissioner Dr. Robert Califf and Center for Drug Evaluation and Research director Dr. Patrizia Cavazzoni to postpone the January 6, 2023 Prescription Drug User Fee Act deadline.

“We urge a postponement of the PDUFA date so the drug can be discussed before an advisory committee meeting, rather than being perceived as yet another Biogen/FDA done deal,” wrote Dr. Wolfe.

The letter notes that lecanemab investigators have concluded that longer trials are needed to determine the efficicacy and safety of lecanemab in early Alzheimer’s disease, and that three deaths thought to be related to the drug have now occurred in lecanemab subjects.

The letter comes on the heels of a congressional report critiquing the approval process of Aduhelm, Biogen’s Alzheimer’s disease drug. Dr. Wolfe cites the June 2021 approval of the drug, despite almost unanimous opposition of FDA’s advisory committee.

“This Friday’s scheduled FDA expedited approval of lecanemab, absent any advisory committee input, would demonstrate that the agency is unwilling or unable to learn from its worst approval mistake — aducanumab — I have ever seen in 50 years of FDA watching,” concludes the letter. “It seems the unprecedented aducanumab FDA/Biogen axis is still in place.”