ARTICLE | Regulation
Three reasons why FDA’s meeting to discuss lecanemab will be less contentious than its aducanumab meeting
By Selina Koch, Executive Editor
June 8, 2023 1:29 AM UTC
Friday’s panel meeting to discuss Eisai’s Alzheimer’s therapy Leqembi appears set to avoid the drama of the fateful Aduhelm meeting two and half years ago. That’s partly because the efficacy picture is clearer this time around. It’s also not the same panel. But a big factor might be FDA’s decision to seek guidance on the drug’s safety in three high-risk subgroups, which could avoid the heavy-handed overselling of the data that alienated the panel last time, and half the biomedical community with it.
The last time FDA convened an advisory committee to discuss the performance of an anti-amyloid mAb in Alzheimer’s patients, it did not go well. The agency was convinced that Aduhelm aducanumab was effective, despite a dataset that came from two trials that had been terminated for futility. FDA reviewers presented their arguments to the panel, which leaned heavily on post hoc analyses, using strong language such as “robust,” “extremely persuasive” and “overwhelming.”…
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- Source: https://www.biocentury.com/article/648220/leqembi-fda-s-chance-for-an-alzheimer-s-do-over
