The US Food and Drug Administration (FDA) has granted Biogen and Eisai’s aducanumab and accelerated approval, making it the first new treatment approved for Alzheimer's disease in over a decade.
The accelerated approval for aducanumab – now known as Aduhelm – is supported by three studies of the drug involving 3,482 patients.
In these studies, patients receiving the treatment had significant dose- and time-dependent reduction of amyloid beta plaque, whereas patients in the control arm experienced no reduction.
Although the exact causes of Alzheimer’s are not fully known, it is characterised by changes in the brain, including amyloid plaques and neurofibrillary or tau tangles.
“This historic moment is the culmination of more than a decade of groundbreaking research in the complex field of Alzheimer’s disease. We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come,” said Michel Vounatsos, chief executive officer at Biogen.
“We are grateful for the contributions of thousands of patients and caregivers who participated in our clinical trials, as well as for the dedication of our scientists and researchers. Together with the healthcare community, we are ready to bring this new medicine to patients and begin to address this growing global health crisis,” he added,
The continued approval of Aduhelm in Alzheimer’s is contingent on the verification of its clinical benefit in confirmatory trials.
“This FDA drug approval ushers in a new era in Alzheimer’s treatment and research. History has shown us that approvals of the first drug in a new category invigorates the field, increases investments in new treatments and encourages greater innovation. We are hopeful and this is the beginning — both for this drug and for better treatments for Alzheimer’s,” said Maria Carrillo, chief science officer of the Alzheimer’s Association.