Efficacy Signal For Lilly’s Solanezumab Stirs The Alzheimer’s Pot
With the potential for a multi-billion-dollar blockbuster on its hands, Eli Lilly could conduct a confirmatory trial or even seek near-term approval of sola after pooled data revealed a hint of disease modifying potential in mildly affected Alzheimer’s patients, though the company also may be grasping at straws.
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There was nothing to be thankful about from Lilly’s disclosure that its potential Alzheimer’s therapy solanezumab failed to demonstrate significant improvement in cognition in a third large Phase III trial. But it does reinforce the wisdom of FDA’s standards for subgroup analysis in failed trials.
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.
Gold standard outcome for Alzheimer's trials may have its difficulties, especially with rater error, but experts say there's no proven alternative to ADAS-cog.