Aduhelm Approved for Alzheimer's Disease

Aduhelm (aducanumab), developed by Biogen and Eisai, was approved by the U.S. Food and Drug Administration in June 2021, making it the first disease-modifying therapy for the treatment of Alzheimer’s disease. It is designed to reduce the number of amyloid plaques present in the brain, potentially slowing neurodegeneration and disease progression. Learn more about this therapy and its path to approval below.

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Aduhelm approved

FDA Approves Aduhelm, First Targeted Alzheimer’s Therapy

For the first time in almost 18 years, the U.S. Food and Drug Administration (FDA) has approved a new treatment — Aduhelm, also known as aducanumab — for Alzheimer’s disease, and a first targeted treatment for patients. With this approval, Aduhelm becomes the first disease-modifying therapy for Alzheimer’s, and…

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Congress requests data on Aduhelm approval | Alzheimer's News Today | Clinical Trials | Illustration of speaker at podium

Congress Asks FDA for More Information on Aduhelm Approval

Federal lawmakers are asking the U.S. Food and Drug Administration (FDA) to provide additional data and documents related to the agency’s controversial decision to grant accelerated approval to Biogen‘s Aduhelm (aducanumab) as a treatment for Alzheimer’s disease. U.S. Rep. Frank Pallone, Jr., chair of the House Committee on…

Aduhelm data presented

#AAIC21 – Aduhelm Shows Range of Benefits in EMERGE

Treatment with Aduhelm (aducanumab) slows the clinical decline observed in in Alzheimer’s across a range of cognitive and functional measurements, according to a new analysis of data from a Phase 3 clinical trial. The results were presented at the Alzheimer’s Association International Conference (AAIC) 2021, held July 26–30 both…

ACD856 multiple ascending dose study

#AAIC21 – New Analyses Support Aduhelm’s Effects on Cognition

In clinical trials of the Alzheimer’s treatment Aduhelm (aducanumab), participants who experienced a greater reduction in brain levels of amyloid plaques — the abnormal protein clumps targeted by the treatment — tended to also experience a greater treatment benefit, in terms of cognition and functional ability, according to new…

Aduhelm for Alzheimer's | Alzheimer's News Today | important annoucement

#AAIC21 – Expert Group Publishes Guidance on Aduhelm’s Use

A panel of experts has crafted guidance for clinical use of Aduhelm (aducanumab), the first targeted treatment for Alzheimer’s disease recently granted accelerated approval by the U.S. Food and Drug Administration (FDA). The recommendations include criteria for determining those patients most appropriate for this once-monthly infusion treatment, and for…

Aduhelm for Alzheimer's | Alzheimer's News Today | important annoucement

Aduhelm Most Appropriate for Early-stage Alzheimer’s, Experts Say

Aduhelm (aducanumab), approved for Alzheimer’s disease in the U.S., is most appropriate for people with mild cognitive impairment (MCI) due to the disease or early Alzheimer’s dementia, the disorders for which it was tested in clinical trials and subsequently approved, according to experts from the scientific community. The experts…