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Trials of aducanumab in Alzheimer disease were previously discontinued following a phase III futility analysis, but Biogen now says that additional data indicate that longer exposure to the higher dose might be effective. The company is seeking FDA approval for the treatment; however, the limited data released do not establish efficacy.
The FDA approvals of siponimod and cladribine for secondary progressive multiple sclerosis raise questions about the diagnostic criteria for multiple sclerosis phenotypes and their applicability to clinical trials. A simpler classification for the disease could be the answer.
Inflammatory processes contribute to neurological disorders, and many therapeutic breakthroughs in neurological disease have been immune-targeted. The choice of neuroinflammation as the theme for the 5th European Academy of Neurology Congress in 2019 and of this Focus issue highlights its importance to neurologists across the discipline.
In the march towards disease-modifying treatments for Alzheimer disease, immunotherapy with antibodies against amyloid-β protein is furthest along in human trials. The news that Biogen’s aducanumab showed no cognitive benefit in phase III trials requires careful analysis of what went wrong and how to position anti-amyloid agents among other therapeutic approaches.
