News
EMA accepts for review MAA for aducanumab treatment for mild Alzheimer’s disease. Eisai + Biogen.
Biogen and Eisai, Co., Ltd. announced that the European Medicines Agency (EMA) has confirmed it has accepted for review, following a standard timetable, the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease. Clinical data from patients with Mild Cognitive Impairment due to Alzheimer’s disease and mild Alzheimer’s disease demonstrate that treatment with aducanumab resulted in the removal of amyloid beta and better clinical outcomes.
If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease. Aducanumab is also under review with the FDA with Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of March 7, 2021..
Condition: Alzheimers
Type: drug
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