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