An Alzheimer’s Win: How Lilly Designed Donanemab Trial To Succeed
Phase II Results May Support Accelerated Approval
Lilly took a different path to positive results in Alzheimer’s with a smaller, biomarker-driven study to test the hypothesis that rapid, robust clearance of amyloid could slow disease progression, CEO David Ricks explains at J.P. Morgan.
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The aducanumab review involved everything sponsors might think they could want from the US FDA, with the agency taking a hands on approach to expedite a complex and difficult review in hopes of delivering an important new therapy to patients as quickly as possible. Unfortunately, in this case, FDA seems to have expedited the review right over a cliff.
The Phase III failure of the Alzheimer’s treatment was largely expected, but is nonetheless a disappointment for the disease and for the anti-amyloid field, casting a shadow over other therapies in development, including Lilly’s own pipeline.