FDA, in Reversal, Limits Aduhelm’s Use to People With Mild Disease

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FDA, in Reversal, Limits Aduhelm’s Use to People With Mild Disease
July 13, 2021July 13, 2021
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The U.S. Food and Drug Administration (FDA) has pulled back the controversial and sweeping approval recently given to Aduhelm (aducanumab), updating the treatment’s label at its manufacturer’s request so that it is prescribed to early-stage Alzheimer’s patients only rather than all with this disease. Whereas the FDA’s original June approval indicated simply that Aduhelm could be used “for the treatment of Alzheimer’s disease,” the updated label is more restrictive. “Treatment with Aduhelm should be initiated in patients with mild cognitive…

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