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FDA Approves Aducanumab the first new treatment for Alzheimer’s disease in nearly 20 years

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the staff of the Ridgewood blog

Ridgewood NJ, Aducanumab is the first new treatment for Alzheimer’s disease that has been approved for use in the US in nearly 20 years. It targets the underlying cause of the disease rather than its symptoms. While it is not a miracle drug, its approval will be a huge boost to dementia research. Alzheimer’s disease affects more than 30 million people around the world, most over the age of 65.

Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for ADUHELM™ (aducanumab-avwa) 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.

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).

“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,” said Michel Vounatsos, Chief Executive Officer at Biogen. “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. Together with the healthcare community, we are ready to bring this new medicine to patients and begin to address this growing global health crisis.”

“Eisai has been working on the creation of new treatments for Alzheimer’s disease since the early 80s through our relentless pursuit to understand the root causes of this disease, and we have spent more than a quarter of a century with people living with Alzheimer’s disease to understand their needs,” said Haruo Naito, Chief Executive Officer at Eisai. “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.”

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 [p

2 thoughts on “FDA Approves Aducanumab the first new treatment for Alzheimer’s disease in nearly 20 years

  1. I had Biogen stock but sold it before it took off.

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