Biogen Alzheimer’s Drug Wins OK
- Posted by ISPE Boston
- On June 10, 2021
The FDA has granted accelerated approval to Biogen and Eisai for Aduhelm™ (aducanumab-avwa), a human monoclonal antibody, as the first and only Alzheimer’s disease treatment to address a defining pathology of the disease by reducing amyloid beta plaques in the brain. Biogen licensed Aduhelm from Neurimmune in 2007 under a collaborative development and license agreement. Since October 2017, Biogen and Eisai have collaborated on the development and commercialization of Aduhelm globally.
The accelerated approval has been granted based on data from clinical trials demonstrating the effect of Aduhelm on reducing amyloid beta plaques, a biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline. Continued approval for Aduhelm’s indication as a treatment for Alzheimer’s disease may be contingent upon verification of clinical benefit in confirmatory trial(s).
The efficacy of ADUHELM was evaluated in two Phase 3 clinical trials—EMERGE (Study 1) and ENGAGE (Study 2)—in patients with early stages of Alzheimer’s disease (mild cognitive impairment and mild dementia) with confirmed presence of amyloid pathology. The effects of ADUHELM were also assessed in the double-blind, randomized, placebo-controlled, dose-ranging Phase 1b study, PRIME (Study 3). In these studies, ADUHELM consistently showed a dose- and time-dependent effect on the lowering of amyloid beta plaques (by 59 percent in ENGAGE, 71 percent in EMERGE, and 61 percent in PRIME).
“Today’s approval of Aduhelm is a transformational breakthrough in the fight to stop this horrible disease. After years of disappointment and despair, this decision offers new hope for many families and a trigger for future investment and innovation,” said George Vradenburg, Chairman and Co-Founder of UsAgainstAlzheimer’s. “Because Aduhelm was studied in people with early-stage Alzheimer’s disease, it will be important for our nation’s healthcare system—patients, providers and payers—to be ready for earlier detection, diagnosis and intervention in the treatment of the disease.” (Source: Biogen Website, 07 June, 2021)