Biogen Submits Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer's Disease

Today, Biogen and Eisai jointly announced that Biogen has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), seeking approval for the investigational drug aducanumab for the treatment of Alzheimer’s disease (AD). This application includes clinical data from the Phase 3 EMERGE and ENGAGE trials, as well as the Phase 1b PRIME trial. Biogen is also requesting Priority Review designation. If approved, aducanumab would become the first FDA-approved therapy to slow the decline of clinical symptoms in Alzheimer’s disease, and 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 cognition, memory, and independence, leading to premature death. This condition represents an escalating 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 obtained the development license 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% (p=0.01) at 78 weeks compared with placebo. Aducanumab also met multiple secondary endpoints in the EMERGE trial.

▲Primary and secondary endpoint data from the EMERGE and ENGAGE clinical trials; the red box indicates changes in CDR-SB scores for the high-dose group (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 both 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.

“Alzheimer’s disease remains one of the greatest public health challenges of our time,” said Michel Vounatsos, Chief Executive Officer of Biogen. “It robs patients of their memory, independence, and ultimately, the ability to perform basic tasks that we hold dear in our loved ones. We look forward to the FDA’s review of our application.”

References:

[1] BIOGEN COMPLETES SUBMISSION OF BIOLOGICS LICENSE APPLICATION TO FDA FOR ADUCANUMAB AS A TREATMENT FOR ALZHEIMER’S DISEASE. Retrieved July 8, 2020, from https://investors.biogen.com/news-releases/news-release-details/biogen-completes-submission-biologics-license-application-fda

Original Title: Biogen Submits Marketing Application for Amyloid Antibody Aducanumab to Treat Alzheimer’s Disease

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