Lecanemab has been presented as safe and effective, yielding a "27% slowing of cognitive decline" and giving much hope to patients. As the FDA prepares to determine if it will grant full approval for its widespread use, the available data suggests lecanemab is ineffective and may be harmful, making its use and cost unjustifiable. 

Lecanemab does not improve patients. On or off lecanemab, participants continued to decline in the clinical trial. On an 18-point scale, lecanemab-treated patients worsened by 1.21 points, while patients on placebo worsened by 1.66 points. This “improvement” (0.45 points) is not a change that patients or their families could perceive (1-2 points). If 100 words represented perfect recall and we started the trial remembering 82, after 18 months with biweekly infusions, we could remember 75 or 76, and without, 73. That's an absolute difference of only 2.5%.

Lecanemab may be harmful. Brain swelling occurred in 13% and small hemorrhages in 17% of treated patients. The long-term consequences of these changes are unknown, but the size of the brains of people on lecanemab decreased significantly. A decrease in brain size is typically seen as a sign of brain degeneration. Also, three deaths have been tied to lecanemab treatment.

Lecanemab is too expensive. The drug is priced at US$26,500 per year, many times the price of a traditional Alzheimer’s medicine such as donepezil, whose benefit is modest yet larger than lecanemab's. Treating just one-tenth of the 6.7 million Americans believed to suffer from Alzheimer's would erode the Medicare budget and hit patients and their families with about US$7,000 in co-payments per year, with no noticeable improvement and potential worsening.

We recommend halting the use of lecanemab and its full approval by the FDA. 

 

Abass Alavi, Hospital of the University of Pennsylvania, Philadelphia, PA, USA

Jorge R. Barrio, University of California Los Angeles, LA, CA, USA

Alberto J. Espay, University of Cincinnati, Cincinnati, OH, USA

Karl Herrup, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA

Poul F. Høilund-Carlsen, University of Southern Denmark, Odense, Denmark

Kasper P. Kepp, Technical University of Denmark, Copenhagen, Denmark

Rachael L. Neve, Massachusetts General Hospital, Boston, MA, USA

George Perry, University of Texas at San Antonio, San Antonio, TX, USA

Mona-Elisabeth Revheim, Oslo University Hospital, Oslo, Norway

Nikolaos Robakis, Icahn School of Medicine at Mount Sinai, New York, NY, USA

Stefano Sensi, University G. d'Annunzio of Chieti-Pescara, Italy

Bryce Vissel, University of New South Wales Medicine & Health, Sydney, Australia

 

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