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Lecanemab Gets Priority Review for Early Alzheimer Disease

The FDA has accepted for Priority Review the BLA for lecanemab for the treatment of early Alzheimer disease.

Haruo naitoDrug administrationPriority reviewBiologics license applicationAlzheimer disease composite scoreClinical dementia rating sum of boxesAlzheimer disease assessment scale cognitivePrescription drug user fee actChief executive officer

Lecanemab Gets Priority Review for Early Alzheimer Disease

The FDA has accepted for Priority Review the BLA for lecanemab for the treatment of early Alzheimer disease.

Haruo naitoDrug administrationPriority reviewBiologics license applicationAlzheimer disease composite scoreClinical dementia rating sum of boxesAlzheimer disease assessment scale cognitivePrescription drug user fee actChief executive officer

Investigational Alzheimer Disease Treatment Granted Fast Track Status

The BLA includes data from a phase 2b trial in 856 individuals with early AD and confirmed amyloid pathology.

Drug administrationFast trackBiologics license applicationAlzheimer disease composite scoreClinical dementia rating sum of boxesAlzheimer disease assessment scale cognitiveBreakthrough therapy

Investigational Alzheimer Disease Treament Granted Fast Track Status

The BLA includes data from a phase 2b trial in 856 individuals with early AD and confirmed amyloid pathology.

Drug administrationFast trackBiologics license applicationAlzheimer disease composite scoreClinical dementia rating sum of boxesAlzheimer disease assessment scale cognitiveBreakthrough therapy

Eisai Begins Rolling BLA Submission of Lecanemab for Early Alzheimer Disease

Eisai Begins Rolling BLA Submission of Lecanemab for Early Alzheimer Disease
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Jeffrey cummingsGrundy centerDrug administrationUniversity of nevada las vegasBiologics license applicationAlzheimer disease composite scoreClinical dementia rating sum of boxesAlzheimer disease assessment scale cognitiveChambers grundy centerTransformative neuroscienceNevada las

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