Biogen and Eisai have been granted accelerated approval by the US FDA for Aduhelm (aducanumab-avwa) as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain.
The accelerated approval has been granted based on data from clinical trials demonstrating the effect of Aduhelm on reducing amyloid beta plaques, a biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.
Continued approval for Aduhelm’s indication as a treatment for Alzheimer’s disease may be contingent upon verification of clinical benefit in confirmatory trial(s).
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).
As part of the accelerated approval, Biogen will conduct a controlled trial to verify the clinical benefit of ADUHELM in patients with Alzheimer’s disease.
Dr. Stephen Salloway, Director of Neurology and the Memory and Aging Program at Butler Hospital, said: “This approval represents a major advance in the treatment of Alzheimer’s disease.
“By reducing amyloid beta plaques in the brain, we are addressing one of the defining pathologies of the disease. People with Alzheimer’s disease, together with their doctors, can now decide if the treatment is right for them.”