Drug manufacturer, Biogen, has decided to discontinue the manufacturing of Aduhelm™ (aducanumab-avwa) injection and to terminate the clinical trial that was being conducted for its full approval. In June 2021, Aduhelm™ was awarded the FDA’s Accelerated Approval and became a landmark event for the Alzheimer’s field, providing hope for the millions of people living with early Alzheimer’s, as it was the first FDA-approved treatment to address one of the underlying causes of the disease. The accelerated approval was surrounded by controversy as many payers did not cover the medication due to lack of clinical trial data to ensure its benefits outweighed its risk. Biogen made the decision based on business purposes and will refocus efforts and financial resources on its Leqembi® (lecanemab-irmb) injection and on investigational drugs still in clinical trials for the disease. Leqembi® was fully approved by the FDA to treat mild Alzheimer’s disease on July 6, 2023. Aduhelm™ and Leqembi® are currently excluded on ProAct’s Advantage formulary.
