Marisa Wexler, MS, senior science writer —

The U.S. Food and Drug Administration (FDA) has agreed to review an application from Eisai seeking accelerated approval of lecanemab (BAN2401), an investigational amyloid-targeting antibody to treat early Alzheimer’s disease in people with confirmed amyloid plaques in the brain. Eisai finished the rolling application a few months ago.

Hoth Therapeutics and Washington University have agreed to extend preclinical research into HT-ALZ, Hoth’s experimental therapy for Alzheimer’s disease. Research findings are expected to be helpful in estimating the best dose of HT-ALZ to test in potential clinical trials, according to a company press release. Hoth entered into…

Alzheimer’s patients given the experimental tau-targeting therapy HMTM in a Phase 3 clinical trial experienced a substantially slower decline in cognitive and functional measures than would be expected based on published research, according to new findings announced by HMTM’s developer TauRx Pharmaceuticals. TauRx expects these results will…

The U.S. Food and Drug Administration (FDA) has granted marketing permission to a new test that checks for amyloid plaques in people being checked for Alzheimer’s disease. The Lumipulse G β [beta]-Amyloid Ratio (1-42/1-40) test, which will be sold by Fujirebio Diagnostics, is now approved for adults ages…

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…

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Biogen has withdrawn its application seeking approval of Aduhelm (aducanumab) to treat early Alzheimer’s disease in the European Union.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…

Most adults in the U.S., as well as many doctors, have difficulty distinguishing between the early stages of Alzheimer’s disease and cognitive changes due to normal aging, according to the latest annual report from the Alzheimer’s Association. The report draws on responses to surveys, one of adult Americans…

Fosgonimeton, an experimental therapy Athira Pharma is developing to treat Alzheimer’s disease, was well-tolerated overall in a Phase 1 clinical trial that included Alzheimer’s patients as well as healthy volunteers. “These encouraging results showed a positive safety and tolerability profile of fosgonimeton across a wide dose range,” Hans Moebius,…