[2][3] It is a monoclonal antibody[3][2] that targets aggregated forms (plaque)[4][5] of amyloid beta (Aβ) found in the brains of people with Alzheimer's disease to reduce its buildup.
[14] In November 2020, a panel of outside experts for the FDA concluded that a pivotal study of aducanumab failed to show strong evidence that the medication worked, citing questionable efficacy and multiple red flags found with the data analysis.
[3][17] The Office of Inspector General, US Department of Health and Human Services was asked to investigate interaction between the drug company and the FDA prior to the medication's approval.
[2] Aducanumab is a monoclonal IgG1 antibody that binds to the amyloid beta protein at amino acids 3–7, which is posited to result in slowing the progression of Alzheimer's disease.
[21] The most common serious adverse reactions reported are:[2] Aducanumab was developed by Biogen Inc., which licensed the medication candidate from Neurimmune, who discovered it with the University of Zurich.
[24] A phase Ib study was published in August 2016, based on one year of "monthly intravenous infusions" of aducanumab, which brain scans to measure amyloid plaques.
[32] On 22 October 2019, Biogen announced that it would be restarting the FDA approval process for aducanumab stating that analysis of a larger dataset from its Phase 3 trials[33][34][35] showed that the drug reduced clinical decline in patients with early Alzheimer's disease when given at higher doses.
[39] In November 2020, a panel of outside experts on the FDA's Peripheral and Central Nervous System Advisory Committee concluded that a pivotal study of aducanumab failed to show "strong evidence" that the medication worked, along with potential safety issues, and suggested that the FDA not approve aducanumab, citing questionable efficacy and multiple "red flags" found with the data analysis.
Coverage for aducanumab will be limited to individuals participating in randomized controlled trials to confirm the efficacy and safety for the Medicare population.
[48] The June 2021 approval of the medication by the US Food and Drug Administration (FDA) was controversial because clinical trials gave conflicting results on its effectiveness.
[13][15][49][50][51] Specific criticisms of the approval included: insufficient evidence of efficacy, that the drug offers false hope, and that the high cost will adversely impact patient finances and Medicare budget.
[52][13] Ten of the eleven outside experts that had served on the FDA's Peripheral and Central Nervous System Advisory Committee voted in November 2020 against approving aducanumab.
"[60] According to a 2022 report released by two House committees,[61] FDA and Biogen worked in concert to receive accelerated approval at a cost to patients of $56,000 a year.
[61] Aware that the high price would trigger "pushback" from payers and providers, "Biogen developed an external narrative about the drug's value to sell to the patients and the public."
[78][11] An initial brain positron emission tomography (PET scan) is required to detect the presence of amyloid beta; since 2013, it has not been covered by Medicare,[79][80] and as of 2018, can cost $2,250 – $10,700.