Biogen’s Aduhelm (aducanumab) Granted Accelerated Approval for Alzheimer’s Disease

Biogen and collaboration partner Eisai announced the U.S. FDA has granted accelerated approval for Aduhelm (aducanumab-avwa) for the treatment of Alzheimer’s disease. The accelerated approval was based on data from clinical trials demonstrating the effect of Aduhelm on reducing amyloid beta plaques, thus leading to a reduction in clinical decline. Continued approval for Aduhelm may be contingent upon verification of clinical benefit in confirmatory trial(s).

The development path for Aduhelm has been a rocky one. In March 2019, Biogen and Tokyo-based Eisai announced they were discontinuing the global Phase III clinical trials, ENGAGE and EMERGE, in patients with mild cognitive impairment for Alzheimer’s and mild Alzheimer’s dementia. The EVOLVE Phase II trial and the long-term extension PRIME Phase Ib trial were also discontinued. The decision was made based on the recommendation of an independent data monitoring committee, which indicated the trials were unlikely to hit their primary endpoint. 

However, in October 2019, the two companies announced plans to pursue regulatory approval for the drug, as the Phase III EMERGE trial met its primary endpoint, showing a significant decrease in clinical decline. Biogen presented data from a subset of patients that received a high enough dose of the drug had significant benefits on measures of cognition and function, including memory, orientation, and language, as well as benefits on activities of daily living.

The FDA approval was based on EMERGE and ENGAGE—in patients with early stages of Alzheimer’s disease (mild cognitive impairment and mild dementia) with confirmed presence of amyloid pathology – as well as the PRIME study. 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.

About Aduhelm (aducanumab-avwa)

Aduhelm (aducanumab-avwa), a human monoclonal antibody, is the first and only Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain. 

Biogen licensed Aduhelm from Neurimmune in 2007 under a collaborative development and license agreement. Since October 2017, Biogen and Eisai have collaborated on the development and commercialization of Aduhelm globally.