Alzheimer's Disease Therapy Seeks FDA Approval
Biogen aducanumab found pharmacologically and clinically active as determined by dose-dependent effects in reducing brain amyloid
An analysis of larger datasets showed that Aducanumab reduced the clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified primary and secondary endpoints, announced Biogen and Eisai Co. in a press release.
This is important news since there is currently no known cure for Alzheimer’s disease, which is the 6th leading cause of death among US adults.
Aducanumab is an investigational human monoclonal antibody studied for the treatment of early Alzheimer’s disease, which is a leading cause of dementia.
Additionally, Biogen and Eisai announced plans to pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer’s disease (AD), with the U.S. Food and Drug Administration (FDA).
If approved, aducanumab would become the first therapy to reduce the clinical decline of AD and would also be the first therapy to demonstrate that removing amyloid-beta resulted in better clinical outcomes.
The decision to file is based on a new analysis, conducted by Biogen in consultation with the FDA, of a larger dataset from the Phase 3 clinical studies that were discontinued in March 2019 following a futility analysis.
This new analysis shows that aducanumab is pharmacologically and clinically active as determined by dose-dependent effects in reducing brain amyloid and in reducing clinical decline as assessed by the pre-specified primary endpoint Clinical Dementia Rating-Sum of Boxes (CDR-SB).
Michel Vounatsos, Chief Executive Officer at Biogen, said in this press release, “We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of AD and the potential implication of these results for similar approaches targeting amyloid-beta.”
Based on discussions with the FDA, the Company plans to file a Biologics License Application (BLA) in early 2020 and will continue dialogue with regulatory authorities in international markets including Europe and Japan.
The BLA submission will include data from the Phase 1/1b studies as well as the complete set of data from the Phase 3 studies.
The Company aims to offer access to aducanumab to eligible patients previously enrolled in the Phase 3 studies, the long-term extension study for the Phase 1b PRIME study, and the EVOLVE safety study.
Biogen will work towards this goal with regulatory authorities and principal investigators with a sense of urgency.
EMERGE and ENGAGE were Phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab.
Although scientists are learning more every day they still do not know what causes Alzheimer’s disease. There probably is not one single cause, but several factors that affect each person differently says the Centers for Disease Control and Prevention (CDC).
AD is a progressive disease beginning with mild memory loss possibly leading to loss of the ability to carry on a conversation and respond to the environment.
Death rates for Alzheimer’s disease are increasing, unlike heart disease and cancer death rates that are on the decline.
Dementia, including Alzheimer’s disease, has been shown to be under-reported in death certificates and therefore the proportion of older people who die from Alzheimer’s may be considerably higher, says the CDC.
Since October 2017 Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally.
Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. Visit BioGen to learn more.
Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. Visit Eisai for more information.
Alzheimer’s disease news published by Precision Vaccinations