Global pharmaceutical company Eli Lilly and Company (NYSE:LLY) announced on Thursday that the European Commission (EC) has granted marketing authorisation for Kisunla (donanemab) for the treatment of early symptomatic Alzheimer's disease (AD) in adults with mild cognitive impairment and those with mild dementia stages of AD with confirmed amyloid pathology who are apolipoprotein E (ApoE4) heterozygotes or non-carriers.
Kisunla is the only once-monthly amyloid plaque-targeting therapy with evidence supporting completing course of treatment once amyloid is decreased to minimal levels.
According to Lilly, treatment with Kisunla slows disease progression which may help preserve cognitive function and independence longer. Data has also shown that Kisunla can significantly reduce the risk of progressing to the next clinical stage of disease over 18 months.
Marketing authorisation was granted based on the TRAILBLAZER-ALZ 2 and TRAILBLAZER-ALZ 6 clinical trials.
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