The FDA accelerates the approval of ADUHELM as the first and only treatment for Alzheimer’s disease that solves the clear pathology of Alzheimer’s disease


-The accumulation of beta amyloid plaques in the brain is the defining pathology of Alzheimer’s disease
-In clinical trials, ADUHELM reduced beta amyloid plaques by 59% to 71% after 18 months of treatment

Tokyo, June 8, 2021-(JCN Newswire)-Biogen (Nasdaq: International Commercial Bank) And Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has approved accelerated approval of ADUHELM (aducanumab-avwa) as the first and only Alzheimer’s solution to clear pathology Disease treatment methods reduce the disease by reducing amyloid beta plaques in the brain.

Accelerated approval is granted based on data from clinical trials that demonstrate the effect of ADUHELM on the reduction of amyloid plaques, which is a biomarker that is reasonably likely to predict clinical benefit, in this case, the reduction in clinical decline . Continuing to approve the indication of ADUHELM as a treatment for Alzheimer’s disease may depend on the verification of clinical benefit in confirmatory trials.

“This historic moment is the culmination of more than a decade of pioneering research in the complex field of Alzheimer’s disease. We believe that this first-class drug will change the treatment of patients with Alzheimer’s disease and stimulate continuous innovation over the years. , Come on,” said Biogen CEO Michel Vounatsos. “We are grateful for the contributions of thousands of patients and caregivers who participated in our clinical trials, as well as the dedication of our scientists and researchers. Together with the healthcare community, we are ready to bring this new drug to patients and begin to respond to this increasing A serious global health crisis.”

“Since the early 1980s, Eisai has been committed to creating new treatments for Alzheimer’s disease. Through our unremitting pursuit of understanding the root causes of this disease, we have spent more than a quarter of a century with People with Alzheimer’s disease understand their needs together,” said Eisai CEO Haruo Naito. “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 may bring hope to global health, society, and most importantly, the future of patients and patients. Their Family, it represents a big step towards developing a holistic ecosystem solution 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) and confirmed the existence Amyloid pathology. The effect of ADUHELM was also evaluated in a double-blind, randomized, placebo-controlled, dose range phase 1b study PRIME (Study 3). In these studies, ADUHELM consistently showed a dose- and time-dependent effect in reducing amyloid plaques (59% reduction [p<0.0001] In ENGAGE, 71% [p<0.0001] In EMERGE and 61% [p<0.0001] In PRIME).

The safety profile of ADUHELM was well characterized in more than 3,000 patients who received at least one dose of ADUHELM. The most frequently reported adverse events are radiological testing of events called amyloid-related imaging abnormalities or “ARIA”. Among patients treated with ADUHELM 10 mg/kg, ARIA (-E and/or -H) was observed in 41% of patients, compared with 10% in the placebo group. Clinical symptoms were observed in 24% of patients receiving ADUHELM 10 mg/kg and ARIA (-E and/or -H), compared with 5% in the placebo group. The most common symptom in patients with ARIA is headache. Other symptoms associated with ARIA include confusion, dizziness, visual disturbances, and nausea. Adverse reactions reported in patients treated with ADUHELM were at least 2% and at least 2% higher than those in the placebo group, including ARIA-E, headache, ARIA-H microbleeds, ARIA-H surface iron deposition, and falls , Diarrhea and confusion/delirium/change of mental state/disorientation.

As part of the accelerated approval, Biogen will conduct a controlled trial to verify the clinical benefits of ADUHELM for patients with Alzheimer’s disease.

Dr. Stephen Salloway, Director of Neurology and Memory and Aging Program at Butler Hospital, said: “This approval represents a major advancement in the treatment of Alzheimer’s disease. By reducing amyloid plaques in the brain, we are solving a decisive problem. The pathology of the disease. Alzheimer’s patients and their doctors can now decide whether treatment is right for them.”

“Today’s approval of ADUHELM is a transformative breakthrough in the fight to contain this terrible disease. After years of disappointment and despair, this decision has brought new hope to many families and triggered future investment and innovation. “Chairman George Vradenburg said. Co-founder of UsAgainstAlzheimer’s. “Because ADUHELM is studied in patients with early Alzheimer’s disease, it is very important for our country’s healthcare system-patients, providers and payers-to prepare for early detection, diagnosis, and intervention in disease treatment. .”

Source: Eisai

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