Eli Lilly and Co has shared full findings of its phase 3 clinical study of donanemab at the Alzheimer’s Association International Conference in Amsterdam which shows that the newly developed drug can modestly slow patients’ inevitable worsening. To put a number, the report claims that the drug can slow down the process 35% or by 4-7 months. Eli Lilly and Co. has said it applied for full US approval of its Alzheimer’s disease drug. If approved this will be the second effective drug to combat the mind-robbing disease, after Japanese drugmaker Eisai developed Leqembi. More than 1,700 patients with early-stage Alzheimer’s disease or mild cognitive impairment received Lilly’s drug or a placebo in the 18-month trial.
Donanemab slowed progression of cognitive and functional decline by 22% on one composite scale and 29% on a similar measure when compared to a placebo. Lilly announced in May that donanemab appeared to work, but on Monday the full results of a study of 1,700 patients was published by the Journal of the American Medical Association and presented at the Alzheimer's conference. Both donanemab and Leqembi are lab-made antibodies, administered by IV, that target one Alzheimer’s culprit, sticky amyloid buildup in the brain.
And both drugs come with a serious safety concern — brain swelling or bleeding that in the Lilly study was linked to three deaths. Scientists say while these drugs may mark a new era in Alzheimer’s therapy, huge questions remain about which patients should try them and how much benefit they’ll really notice. Lilly’s study enrolled people ages 60 to 85 who were in early stages of Alzheimer’s.
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