Author Archives: Marisa Wexler MS

On June 7, Aduhelm (aducanumab) became the first new treatment for Alzheimer’s disease to be approved by the U.S. Food and Drug Administration (FDA) in nearly two decades, and this disorder’s first targeted therapy. Scarcely a month later, the agency took the unusual step of updating…

The U.S. Food and Drug Administration (FDA) has pulled back the controversial and sweeping approval recently given to Aduhelm (aducanumab), updating the treatment’s label at its manufacturer’s request so that it is prescribed to early-stage Alzheimer’s patients only rather than all with this disease.

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…

The National Institute on Aging (NIA) has awarded a five-year grant worth up to $5 million to support a clinical trial that will test AAV2-BDNF, an investigational gene therapy, in people with Alzheimer’s disease or mild cognitive impairment, which often precedes dementia. The therapy aims to deliver the gene BDNF to…

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…

In a few days, the U.S. Food and Drug Administration (FDA) is expected to announce whether or not it decided that aducanumab, an investigational treatment for Alzheimer’s disease developed by Biogen, merits approval and wide…

A draft report from the Institute for Clinical and Economic Review, known as ICER, found that there is insufficient evidence to determine whether the investigational therapy aducanumab will provide health benefits to people with Alzheimer’s disease. ICER is an independent non-profit research institute that works to assess the…

LX1001, a gene therapy for Alzheimer’s disease being developed by Lexeo Therapeutics, has been granted fast track designation by the U.S. Food and Drug Administration (FDA). The therapy is designed to deliver a version of the APOE gene, called APOE2, to cells in the central nervous system (the…

A new Phase 3 clinical trial, called EMBARK, will evaluate the long-term safety and efficacy of aducanumab (BIIB037), an investigational therapy for Alzheimer’s disease in patients who took part in its previous clinical studies. The trial’s design was described by Carmen Castrillo-Viguera, a medical director at Biogen, in the poster “…

Despite minor improvements in recent years, the availability of care for people with dementia in Europe is largely inadequate, according to a new report. The report, “Dementia Monitor 2020,” was published by Alzheimer Europe, an organization that campaigns to ensure that Alzheimer’s disease and dementia are treated…