Biogen (Nasdaq: BIIB) and Eisai (TYO: 4523) have announced that the European Medicines Agency (EMA) has confirmed it has accepted for review the Marketing Authorization Application (MAA) for aducanumab, an investigational treatment for Alzheimer’s disease.
If approved, aducanumab would become the first therapy to reduce the clinical decline in patients with Alzheimer’s disease, though its route to this stage has not been seamless due to earlier mixed trial results.
But Biogen has stressed that clinical data demonstrate that treatment with aducanumab has resulted in the removal of amyloid beta and better clinical outcomes.
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