Biogen and Eisai's Alzheimer’s Therapy Aducanumab Granted FDA Priority Review

On August 7, Biogen and Eisai jointly announced that the Biologics License Application (BLA) for aducanumab, an innovative Alzheimer’s disease therapy developed through their collaboration, has been accepted by the U.S. FDA and granted Priority Review designation, with a PDUFA date of March 7, 2021. The press release stated that, if approved, aducanumab would become the first FDA-approved therapy to slow the decline of clinical symptoms in Alzheimer’s disease, as well as the first therapy to demonstrate that reducing beta-amyloid plaques leads to improved clinical outcomes.

Alzheimer's disease is a progressive neurological disorder that impairs thinking, memory, and independence, leading to premature death. This condition represents a growing global health crisis, affecting both patients and their families. According to data from the World Health Organization (WHO), tens of millions of people worldwide are living with Alzheimer's disease, and this number is projected to continue rising in the coming years.

Aducanumab (BIIB037) is an investigational monoclonal antibody targeting beta-amyloid. Biogen licensed the development rights for aducanumab from Neurimmune. Since October 2017, Biogen and Eisai have been collaborating globally on the development and commercialization of aducanumab.

The clinical development program for aducanumab included two Phase 3 clinical trials, EMERGE and ENGAGE, conducted in patients with early Alzheimer’s disease. The EMERGE clinical trial met its primary clinical endpoint, demonstrating that high-dose aducanumab significantly slowed the decline in a cognitive function score (CDR-SB) by 22% compared with placebo at 78 weeks (p=0.01). Aducanumab also met multiple secondary endpoints in the EMERGE trial.

▲Final Data on Primary and Secondary Endpoints of the EMERGE Trial (Image source: Biogen official website)

Imaging data on amyloid deposition from the EMERGE trial showed that, at 26 and 78 weeks, amyloid plaque burden was reduced in the low-dose and high-dose aducanumab groups compared with placebo (P<0.001). Although the ENGAGE trial did not meet its primary endpoint, Biogen believes that a subset of its data supports the clinical outcomes observed in the EMERGE trial.

Michel Vounatsos, CEO of Biogen Inc., stated: “We look forward to collaborating with the FDA throughout the review process, and we thank the thousands of clinicians, patients, and caregivers who participated in our clinical trials and have accompanied us on this journey. We believe that aducanumab marks the beginning of a new era in potential treatments for Alzheimer’s disease, which will inspire further discovery and innovation, bringing hope to those affected by this devastating condition.”

“Reducing clinical decline and maintaining the ability to live independently for as long as possible are the most important expectations that patients with Alzheimer’s disease and their families have for potential therapies,” said Dr. Haruo Naito, Chief Executive Officer of Eisai Co., Ltd. “If aducanumab is approved, it will transform the lives of patients with Alzheimer’s disease. We believe this historic milestone represents a step toward creating a paradigm shift in the treatment of Alzheimer’s disease.”

References:

[1] FDA Accepts Biogen’s Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review. Retrieved 2020-08-07, from http://www.globenewswire.com/news-release/2020/08/07/2074936/0/en/FDA-Accepts-Biogen-s-Aducanumab-Biologics-License-Application-for-Alzheimer-s-Disease-with-Priority-Review.html

Note: This article aims to introduce advances in pharmaceutical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed medical institution.

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