FDA, Leqembi and Alzheimer's disease

New Maintenance Dosing Option for Alzheimer's Drug Leqembi Offers Flexibility
Fact checked by Nick Blackmer The Food and Drug Administration (FDA) has approved a new maintenance dosing schedule for Leqembi, a monoclonal antibody treatment shown to slow cognitive decline in people with early Alzheimer’s disease.
FDA Approves LEQEMBI® (lecanemab-irmb) IV Maintenance Dosing for the Treatment of Early Alzheimer’s Disease
Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatmentAlzheimer's disease progression does
FDA Approves New IV Maintenance Dose of Leqembi
A monthly 10 mg/mL maintenance dose of Leqembi had the same effects on mild Alzheimer’s symptoms as biweekly dose, research shows.
BIIB Secures FDA Nod for Monthly Maintenance Dosing of Alzheimer's Drug
Biogen BIIB announced that the FDA has approved a monthly maintenance dosing version for its intravenously (IV) administered Alzheimer's disease (AD) drug, Leqembi. Post the FDA approval, patients have the option to transition to a monthly maintenance dosing regimen of Leqembi after completing an 18-month course of biweekly infusions of the drug.
Leqembi Monthly IV Maintenance Dosing Approved for Early Alzheimer Disease
Lecanemab is a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.
FDA Approves Supplemental Biologics License Application for Intravenous Maintenance Dosing of Leqembi in Alzheimer Disease
Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with Alzheimer disease administered Leqembi.
FDA Approves New Maintenance Dosing for Lecanemab to Treat Early-Stage Alzheimer Disease
The FDA approves a new maintenance dosing regimen for lecanemab (Leqembi; Eisai) in patients with early-stage Alzheimer disease (AD), enabling a transition from biweekly to once-every-4-week dosing while preserving clinical and biomarker benefits.
US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug
The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's Alzheimer's drug Leqembi, the companies said on Monday.
USFDA nod to Leqembi IV maintenance dosing for treatment of early Alzheimer's Disease: Eisai, Biogen
Tokyo: Eisai Co., Ltd. and Biogen Inc. have announced that the U.S. Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) for once every four
FDA Approves Once-Every-Four-Weeks Maintenance Dosing Of LEQEMBI For Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced Sunday that the U.S. Food and Drug Administration has approved the
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Biogen, Eisai Win Nod for Monthly Leqembi Maintenance Amid Stagnant Sales
The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for ...
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U.S. health agencies see some chaos — but an FDA approval gets through
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