FDA granted accelerated approval for ADUHELMル as the first and only Alzheimerメs disease treatment

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On Jun. 7, 2021, Biogen and Eisai announced that the U.S. Food and Drug Administration (FDA) had granted accelerated approval for ADUHELMル (aducanumab-avwa) as the first and only Alzheimerメs disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain.

Adverse reactions that were reported in at least 2 percent of patients treated with ADUHELM and at least 2 percent more frequently than in patients on placebo were ARIA-E, headache, ARIA-H microhemorrhage, ARIA-H superficial siderosis, fall, diarrhea, and confusion/delirium/altered mental status/disorientation.

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Source: Biogen
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