On Monday, U.S. regulators approved Biogen Inc.'s aducanumab as the first treatment to address an underlying cause of Alzheimer's disease despite controversy over mixed clinical trial results for the drug.
Aducanumab aims to remove sticky deposits of a protein called amyloid beta from the brains of patients in earlier stages of Alzheimer's in order to stave off its ravages, which include memory loss and the ability to care for one's self. The Food and Drug Administration (FDA) said the clinical trials for the treatment, to be sold under the brand name Aduhelm, showed a reduction in the plaques that is expected to lead to a reduction in the clinical decline of patients.
"Although the Aduhelm data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients," the agency said in a statement.
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