Eli Lilly has received FDA approval for donanemab (Kisunla) for the treatment of early-stage Alzheimer's disease. It joins Leqembi from Eisai/Biogen as the first effective, disease modifying treatments for the disease.
In the Phase III study, patients showed 40% less decline over 18 months in the ability to perform daily activities, and 47% of patients (29% on placebo) showed no cognitive decline over a year.
The approval is good news for Cogstate (CGS: $1.135), which specialises in cognitive assessments for the disease, having recently regained rights to its Cognigram test, which will continue to also be used by Eisai.
The uptake of the new Alzheimer's disease therapies is expected to grow as clinicians better understand how to use the therapies and the side effects. Earlier intervention is expected to have less side effects, however identifying patients at early stages of cognitive decline with a sensitive test such as Cognigram will increase in importance and value.
Kisunla is prescribed as an infusion every four weeks. However of interest is that therapy can be stopped when amyloid plaques reduce to 'minimal levels' as assessed by PET imaging. This will also increase the need to ongoing monitoring of cognitive function.
Cogstate's test is used by Eisai in the US to help identify patients for treatment, and by Eli Lilly in its Alzheimer's disease studies.
Bioshares recommendation (Cogstate): Buy
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