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Aducanumab received accelerated approval from the FDA on June 7, 2021. It was announced on January 31, 2024, that Biogen was discontinuing the production of aducanumab. Patients enrolled in a clinical trial could continue in their studies through May 1, 2024, and patients with prescriptions can continue to receive treatments through November 1, 2024. 

As part of the Accelerated Approval pathway, the sponsor is required to conduct a post-market clinical trial to ensure endpoints are met. The sponsor has up to nine years to complete the trial. If the trial fails to show clinical benefit, the FDA could withdraw approval of the drug. The Â鶹´«Ã½Ó³»­ detailed alternative drug approval pathways in a policy brief.

Amyloid-related imaging abnormalities (ARIA) are the most common side effect in the clinical trials. ARIA occurred in 40% of patients in the trials, was most common in the titration phase, and was more common in patients with ApoE4 genotype. Most patients did not show any symptoms. ARIA is monitored through a series of MRIs. Patients will need an MRI before treatment and then additional MRIs before the seventh and 12th treatments.

The FDA approved the drug for patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

Currently the label does not state how patients need to be diagnosed. In the clinical trial, patients were confirmed to have beta-amyloid via PET scans. CSF testing and PET scans can be used to diagnose patients. The FDA labeling does not require these tests for prescribing aducanumab, but it may be required by CMS or a private payer.

CMS covers aducanumab as long as the patient is enrolled in an approved clinical trial. The Â鶹´«Ã½Ó³»­ recommends members to check their private payer's coverage policies for coverage. 

The Â鶹´«Ã½Ó³»­ developed and released an Evidence in Focus document on February 23, 2022. The document summarizes the level of evidence for aducanumab for patients with Alzheimer’s disease and reviews clinical considerations regarding use. This is not a guideline and does not include recommendation statements.