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FDA approval of Kisunla (Donanemab-azbt) for the treatment of mild cognitive impairment or early-stage Alzheimer’s disease and confirmed amyloid plaques in the brain. Kisunla is the first amyloid plaque-targeting therapy that used a limited-duration treatment regimen based on amyloid plaque removal; nearly half of study participants completed their course of treatment with Kisunla in 12 months. Patients received 700 mg for the first 3 doses and 1400 mg thereafter. Donanemab (LY3002813) is a humanized IgG1 mAb targeted against N-terminal pyroglutamate Aβ and works by inducing microglial-mediated clearance of existing Aβ plaques. Donanemab slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants' risk of progressing to the next clinical stage of disease by up to 39%. This makes 2 disease-modifying amyloid-targeting therapies now available to patients with early AD, as Eisai's Leqembi (Lecanemab) was granted traditional FDA approval on July 6, 2023. https://lnkd.in/dDd2D9ek
