BRIEF—Peer-reviewed publication of Aduhelm Phase III EMERGE and ENGAGE data

A peer-reviewed manuscript detailing data from the much-anticipated pivotal Phase III EMERGE and ENGAGE trials for Aduhelm (aducanumab-avwa) 100mg/mL injection for intravenous use in early Alzheimer’s disease has been published in the Journal of Prevention of Alzheimer’s Disease (JPAD) today, US biotech major Biogen announced.

The publication includes results from the primary, secondary and tertiary endpoints in the trials, as well as safety data and biomarker sub-studies.

The publication may be accessed on the JPAD’s website,  here.

In June 2021, the U PublishS Food and Drug Administration granted accelerated approval for Aduhelm as the first Alzheimer’s disease treatment to address a defining pathology of the 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.

There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Continued approval of Aduhelm for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s), Biogen noted.