Opinion: The FDA needs a risk evaluation and mitigation strategy for Alzheimer’s drug lecanemab
The problem with the new Alzheimer’s drugs isn’t the drugs.
Over the past several months, my conversations with colleagues in the Alzheimer’s field have featured an unusual sentiment: optimism inflected with worry.
Optimism because, after years of failed studies and the disastrous accelerated approval of aducanumab, we’re enjoying a less than one-year-old streak of good news. The latest bright flash is the June 9 Food and Drug Administration hearing on the anti-amyloid antibody lecanemab (to be sold by Eisai as Leqembi). The committee members unanimously agreed that the drug outperformed placebo on multiple measures of cognition, day-to-day function and biomarkers. It’s beneficial. Full approval is almost a certainty. If donanemab’s similar results hold up to scrutiny (the data are limited to a press release, they’ll be presented in full at the Alzheimer’s Association International Conference in July and in a forthcoming paper), it will likely enjoy the same decision.
What's Your Reaction?
