Expert Review of Neurotherapeutics · 2024 · 10 citations · 16 references
MedicinePharmacokineticsPharmacologyDementiaNeurodegenerationNeuropharmacologyAlzheimer DiseaseCognitive ImpairmentDementia TreatmentNeurodegenerative Disease PharmacologyNeurodegenerative DiseasesPharmacokinetics In DementiaAlzheimer's Disease PharmacokineticsAmyloid Beta-targeted TherapyFda Drug RegulationFda RegulationPharmacological Treatment Of DementiaPost-marketing SurveillancePost-marketing Surveillance DataTreatment Of Cognitive Symptoms
INTRODUCTION: In July 2023, the U.S. Food and Drug Administration (FDA) granted full approval to lecanemab for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia. Considering the limited treatment options for AD, the approval of lecanemab offers hope and opens the door for other disease-modifying therapies in the pipeline. AREAS COVERED: In this review, the authors summarize the FDA treatment guidelines, other anti-amyloid agents, and drug information relevant to prescribers, such as pharmacology and pharmacokinetics. Relevant clinical trial outcomes are discussed along with their significance and controversies. EXPERT OPINION: While questions remain about the magnitude of lecanemab's clinical impact, its approval signifies major progress in addressing the underlying pathology of AD. The authors have confidence in lecanemab as a promising treatment option and foresee exciting advancements on the 5-year horizon. Yet, further research is needed regarding trials beyond 18 months, post-marketing surveillance, and lecanameb in combination with existing treatments and lifestyle interventions.
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