Aduhelm mAB Description 2022

Aduhelm (Aducanumab-avwa) is a human, IgG1 monoclonal antibody directed against aggregated soluble and insoluble forms of Aβ1.

It is expressed in a Chinese hamster ovary cell line.

Aduhelm mAB Indication

Aduhelm mAB is indicated to treat Alzheimer's disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of the disease. 

The FDA approved Aduhelm in 2021 based upon the reduction in amyloid-beta plaques observed in clinical trial patients.

Aduhelm is administered intravenously, monthly.

Aduhelm mAB News 2022

January 11, 2022 - Biogen released a statement regarding the Draft National Coverage Determination (NCD). The current draft decision denies nearly all Medicare beneficiaries from accessing Aduhelm.  The final NCD is expected to be issued in April 2022.

September 1, 2016 - Nature reported in patients with prodromal or mild AD, one year of monthly intravenous infusions of aducanumab reduces brain Aβ in a dose- and time-dependent manner. 

Aduhelm mAB Clinical Trials

Biogen has been involved in multiple clinical trials regarding AZD.