Opinion: The FDA needs a risk evaluation and mitigation strategy for Alzheimer’s drug lecanemab
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.
