Currently Enrolling Trials
Aduhelm (aducanumab-avwa) is an amyloid beta-directed antibody.
Aduhelm is specifically indicated for the treatment of Alzheimer’s disease. Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
Aduhelm is supplied as a solution for intravenous injection. After an initial titration, the recommended dosage of Aduhelm is 10 mg/kg. Aduhelm is administered as an intravenous (IV) infusion over approximately one hour every four weeks and at least 21 days apart. The dosing schedule is as follows:
IV Infusion (every 4 weeks) | Aduhelm Dosage (administered over approximately one hour)
Infusion 1 and 2 1 mg/kg
Infusion 3 and 4 3 mg/kg
Infusion 5 and 6 6 mg/kg
Infusion 7 and beyond 10 mg/kg
Mechanism of Action
Aduhelm (aducanumab-avwa) is a human, immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. Aduhelm reduces amyloid beta plaques.
Adverse effects associated with the use of Aduhelm may include, but are not limited to, the following:
- ARIA-H microhemorrhage
- ARIA-H superficial siderosis
Clinical Trial Results
This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial.
Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
The efficacy of Aduhelm was evaluated in two Phase 3 clinical trials—EMERGE (Study 1) and ENGAGE (Study 2)—in patients with early stages of Alzheimer’s disease (mild cognitive impairment and mild dementia) with confirmed presence of amyloid pathology. The effects of ADUHELM were also assessed in the double-blind, randomized, placebo-controlled, dose-ranging Phase 1b study, PRIME (Study 3). In these studies, ADUHELM consistently showed a dose- and time-dependent effect on the lowering of amyloid beta plaques (by 59 percent) in ENGAGE, 71 percent in EMERGE, and 61 percent in PRIME).