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FDA Converts Novel Alzheimer's Disease Treatment to Traditional Approval

Published: July 6, 2023

/PRNewswire/ -- Today, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer's Disease, to...

Source: prnewswire.com

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United StatesTeresa BuracchioOffice Of NeuroscienceEisai IncCentral Nervous System Drugs Advisory CommitteeAlzheimer Disease Cooperative StudyDrug AdministrationAction Follows Confirmatory TrialVerify ClinicalAccelerated ApprovalDrug EvaluationClinical Dementia Rating Scale SumDisease Assessment Scale Cognitive SubscaleDisease Cooperative Study ActivitiesDaily Living ScaleMild CognitiveApril Grant