Biogen shares peer-reviewed publication of Aduhelm phase 3 data

Biogen has announced that a peer-reviewed manuscript has been published in The Journal of Prevention of Alzheimer’s Disease on data from the pivotal phase 3 EMERGE and ENGAGE trials for Aduhelm (aducanumab-avwa) for use in the treatment of early Alzheimer’s disease.

The article includes results from the primary, secondary and tertiary endpoints of the trials, alongside safety data and biomarker sub-studies.

The US Food and Drug Administration (FDA) granted Biogen accelerated approval for Aduhelm in June 2021 as the first Alzheimer’s disease treatment to address a defining pathology of the condition.

Aduhelm is indicated for the treatment of Alzheimer’s disease for patients with mild cognitive impairment or mild dementia – the population in which treatment was initiated in clinical trials.

A defining feature of Alzheimer’s disease is the accumulation of amyloid beta plaques in the brain. The accelerated approval of Aduhelm was based on clinical trial data that detailed the ability of Aduhelm, a monoclonal antibody, to reduce amyloid beta plaques.

There is no safety or effectiveness data on initiating treatment at earlier or later stages of the disease.

Samantha Budd Haeberlein, senior vice president, Head of Neurodegeneration Development at Biogen, said: “We will continue to provide physicians with efficacy and safety data to help them make the best treatment decisions for patients as we learn from our ongoing trials and real-world evidence.”

Speaking on behalf of the Alzheimer Therapeutic Research Institute, University of Southern California, San Diego, Dr Paul Aisen said: “The peer reviewed publication of this data is a testament to the importance of the findings for the scientific and Alzheimer’s disease communities.”

He added: “Alzheimer’s disease is an incredibly complex condition, and this dataset is critical to advancing the understanding of the phase 3 results.”