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.
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…
Biogen is discontinuing development and commercialization of its controversial Alzheimer’s disease treatment Aduhelm (aducanumab) — a move that’s “not related to any safety or efficacy concerns,” the company said in a press release. Instead, according to Christopher Viehbacher, president and CEO of Biogen, the company is…
Eli Lilly’s donanemab was found to work better than Aduhelm (aducanumab) in a biomarker study of people with early Alzheimer’s in removing disease-associated toxic protein clumps in the brain. The experimental therapy outperformed the approved treatment, from Eisai and Biogen, in a Phase 3 clinical trial, according…
Biogen is eliminating corporate infrastructure that had been put in place to support sales of Aduhelm (aducanumab) in the U.S., the company announced. The decision is being made in response to a policy announced last month that Medicare would only cover the cost of Aduhelm for people…
Biogen is continuing to actively recruit Alzheimer’s patients for its Phase 4 ICARE AD-US trial, which is evaluating the long-term safety and effectiveness of Aduhelm (aducanumab) in the real-world U.S. clinical setting. Participants — including a targeted enrollment of 16% Latino and African American patients — are currently being…
A standardized MRI protocol to screen for brain imaging abnormalities in people with Alzheimer’s who are being treated with Aduhelm in a large observational study was described in a presentation at the 2022 American Academy of Neurology (AAN) annual meeting. “Consistency in MRI acquisition is important for efficient and…
Biogen has withdrawn its application seeking approval of Aduhelm (aducanumab) to treat early Alzheimer’s disease in the European Union. A committee of the European Medicines Agency (EMA) recommended against approving Aduhelm late last year. Biogen had requested a re-examination of that decision, made by the Committee for Medicinal Products…
The Centers for Medicare and Medicaid Services (CMS), in a final national policy decision, is allowing Medicare to cover the cost of Aduhelm (aducanumab) and other medicines in its class given accelerated approval only for Alzheimer’s disease patients enrolled in qualifying clinical trials. Should Adulhelm or future amyloid-targeting monoclonal antibodies be…
Biogen, the co-developer of Aduhelm (aducanumab) has submitted the final protocol for ENVISION — the Phase 4 post-marketing study of the therapy in early Alzheimer’s disease — to the U.S. Food and Drug Administration (FDA) for review and approval, the company has announced. Screening of the first…
Discussion
There’s a lot unknown about Alzheimer’s disease, and many myths surround the mind-altering disease. It’s necessary to separate fact from fiction. As misnomers are addressed, it removes some of the stigmas attached to Alzheimer’s. Because knowledge is power, it delivers hope to people who fear developing the most common form…
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