Aduhelm is said to address a defining pathology of Alzheimer’s disease by reducing amyloid beta plaques in the brain
Biogen, together with its partner Eisai, has received the US Food and Drug Administration (FDA) accelerated approval for Aduhelm (aducanumab-avwa) to treat a type of Alzheimer’s disease.
Aduhelm is said to be the first and only treatment to address a defining pathology of Alzheimer’s disease by reducing amyloid beta plaques in the brain.
In the clinical trials, Aduhelm has reduced amyloid beta plaques, a biomarker that predicts clinical benefit, which indicates a reduction in clinical decline in this case.
Continued approval for treating Alzheimer’s disease may be contingent upon verification of clinical benefit in confirmatory trials, said the company.
Biogen chief executive officer Michel Vounatsos said: “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.
“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.”
The US FDA granted accelerated approval for Aduhelm is based on efficacy data from Phase 3 clinical trials, EMERGE and ENGAGE, and dose-ranging Phase 1b study, PRIME.
The studies enrolled 3,000 patients with early stages of Alzheimer’s disease (mild cognitive impairment and mild dementia) with confirmed presence of amyloid pathology.
In the studies, the drug showed a consistent dose- and time-dependent effect on reducing the amyloid beta plaques.
The most frequently reported adverse event was radiographic detection of events termed Amyloid Related Imaging Abnormalities (ARIA).
With the accelerated approval, Biogen will conduct a controlled trial to validate the clinical benefit of Aduhelm in patients with Alzheimer’s disease.
Eisai chief executive officer Haruo Naito said: “We are very pleased to be able to open a new chapter in the history of Alzheimer’s disease treatment with the approval of Aduhelm.
“This approval has the potential to bring hope to the future of global health, society and, most importantly, the patients and their families, and represents a great step toward the advancement of holistic ecosystem solutions for this devastating disease.”
Biogen and Eisai have launched several programmes to support access for all qualified patients, including traditionally underserved populations.
The initiatives are aimed at enabling patients and their families to understand the disease, navigate the diagnostic journey, secure culturally competent care and afford treatment.