Aduhelm
Aduhelm (Aducanumab) is a human, IgG1 monoclonal antibody (mAb) directed against aggregated soluble and insoluble forms of Aβ1. It is expressed in a Chinese hamster ovary cell line. Aduhelm is an amyloid beta-directed antibody indicated to treat Alzheimer’s disease. Aduhelm is approved under the accelerated approval pathway, which provides patients with a serious disease earlier access to drugs when there is an expectation of clinical benefit despite some uncertainty about the clinical benefit.
U.S. Food and Drug Administration (FDA) accelerated approval is based upon the drug’s effect on a surrogate endpoint — an endpoint that reflects the effect of the drug on an essential aspect of the disease — where the drug’s effect on the surrogate endpoint is expected, but not established, to predict clinical benefit. In the case of Aduhelm, the surrogate endpoint is the reduction of amyloid beta plaque. The accelerated approval pathway requires the company to verify clinical benefits in a post-approval trial. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003.
On July 8, 2021, the FDA issued approval to Biogen and Eisai Co., Ltd.
Aduhelm Indication
Aduhelm is administered intravenously monthly. Injection of 100 mg/mL for intravenous use indicated to treat AD
Aduhelm News
June 7, 2023 - The U.S. Food and Drug Administration approved Aduhelm (aducanumab) for treating AD.
January 11, 2022 - Biogen released a statement regarding the Draft National Coverage Determination. The current draft decision denies nearly all Medicare beneficiaries from accessing Aduhelm.
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 Clinical Trials
The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to reduce the clinical decline of this devastating form of dementia.