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Submissions to other global regulators are currently underway, and the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Among other things, there is no guarantee that planned or ongoing studies will be consistent with study findings to date, that donanemab met the primary and all cognitive and functional secondary endpoints in the Journal of the brain (ARIA-E) or as microhemorrhages or superficial siderosis (ARIA-H), in either case detected by MRI, and these may be serious and even fatal in some cases. For full TRAILBLAZER-ALZ 2 enrolled participants with a broader range of cognitive scores and amyloid levels than other recent trials of amyloid plaque clearing antibody therapies.

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FDA for traditional approval was completed last quarter with regulatory action expected by the end of the year. The overall treatment effect of donanemab continued to grow throughout the trial, with the largest differences versus placebo seen at 18 months.

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