Few experts question that Biogen and Eisai’s monoclonal antibody Aduhelm (aducanumab-avwa) clears amyloid beta plaques from the brains of people living with Alzheimer’s disease. Few also question that the build-up of amyloid beta in the brain is a defining pathophysiological feature of the condition.
The US Food and Drug Administration (FDA) confirmed this when announcing the approval of Aduhelm this summer. ‘Aduhelm represents a first-of-its-kind treatment approved for Alzheimer’s disease… [it] is the first therapy that targets the fundamental pathophysiology of the disease,’ said the FDA.
However, since its controversial approval, many academics and clinicians have questioned whether the drug actually halts the cognitive decline that accompanies the underlying pathophysiological changes in the brain.
Following a rocky six months for the therapy, Biogen and Eisai have finally announced their plans to prove that Aduhelm does what it says on the tin. As expected, it is going to take a long time.
“I am very encouraged by… Biogen’s and Eisai’s goal to complete the trial in four years after its initiation, approximately half of the time that the FDA provided as part of the accelerated approval,” said Dr Marwan Sabbagh, professor of neurology, Alzheimer’s and memory disorders at the Barrow Neurological Institute in Phoenix, Arizona.
“This is a significant commitment from the companies. It takes time to execute a complex, global trial of this nature, so I am pleased to see the high level of priority being afforded to this study,” said Professor Sabbagh.
As part of the post-marketing requirements laid down by the FDA’s accelerated approval, a global, placebo-controlled trial involving more than 1,300 people with early Alzheimer’s disease could begin patient screening in May.
With a primary clinical endpoint at 18 months after treatment, the primary completion date is expected to be ‘approximately four years after the study begins’, said the companies. That means 2027 at the earliest.
“We are delivering on our commitment to accelerate the timelines with the goal to complete the confirmatory study well ahead of schedule,” said Dr Priya Singhal, interim head of R&D at Biogen. “Together with EMBARK, Biogen’s redosing study, and the ICARE AD study, we aim to provide data from real-world practice and clinical trials to further inform patient and physician decisions about treatment.”
While Aduhelm remains available to patients in the US for the treatment of mild cognitive impairment or the mild dementia stage of Alzheimer’s, the European Medicines Agency (EMA) has recommended refusing Biogen application for marketing authorisation after its advisory group, the Committee for Medicinal Products for Human Use (CHMP), failed to recommend the therapy.