The U.S. Food and Drug Administration has approved a monthly maintenance dose for Eisai and Biogen’s Alzheimer’s drug, Leqembi, the companies announced on Monday.
Initially granted full U.S. approval in 2023, Leqembi showed effectiveness in slowing cognitive decline in Alzheimer’s patients. However, its growth has been hindered by the time-intensive administration process, which includes regular MRI scans and screenings.
Under the new dosing regimen, patients can transition to a monthly intravenous infusion after completing 18 months of biweekly doses. Alternatively, they may continue the biweekly schedule. Leqembi works by clearing amyloid beta protein deposits in the brain, considered a hallmark of Alzheimer’s. The infusion process at treatment centers typically takes about an hour.
According to the companies, data modeling suggests that the monthly dosing will preserve the drug’s therapeutic benefits.
Leqembi faces competition from Eli Lilly’s Kisunla, approved in July, which also involves monthly infusions. Patients on Kisunla discontinue treatment once brain scans show no amyloid plaques.
Both drugs carry safety warnings for potential brain swelling and bleeding, requiring patients to undergo regular monitoring. Eisai’s collaboration with BioArctic supports Leqembi’s development.
These advancements represent significant progress in Alzheimer’s treatment, providing patients with more flexible dosing options while continuing to address safety concerns.
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