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JULY 12, 2021

FDA Narrows Aduhelm Label

By Gina Shaw

The FDA recently updated the label for aducanumab (Aduhelm, Biogen), the controversial drug for Alzheimer’s disease, which it approved under its accelerated approval pathway on June 7. 

The broadness of the drug’s original label, which said, “Aduhelm is indicated for the treatment of Alzheimer’s disease,” was shocking to many, because the two trials on which its approval was based, EMERGE and ENGAGE, only enrolled individuals with mild cognitive