INDIANAPOLIS (dpa-AFX) - Eli Lilly and Company (LLY) Wednesday said that the U.S. Food and Drug Administration (FDA) has approved a label update for Kisunla with a new dosing recommendation for adults with early symptomatic Alzheimer's disease (AD).
The new dosing recommendation is to start with a single vial and gradually increase dosing to the full 4 vials at month 4. The previous schedule was 2 vials a month for the initial 3 months and full 4-vials dose starting from the fourth month.
The new dosing schedule significantly lowered the incidence of amyloid-related imaging abnormalities with edema/effusion (ARIA-E), a kind of brain swelling, compared to the original dosing schedule.
Kinsula was approved by the FDA in July last year for adults with early symptomatic Alzheimer's disease.
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