Marisa Wexler, MS,  senior science writer—

The U.S. Food and Drug Administration (FDA) has agreed to review a request to convert Leqembi’s (lecanemab) accelerated approval to a traditional approval for treating Alzheimer’s disease. The FDA has granted priority review to the supplemental biologics license application (sBLA) and the agency is expected to make a…

The U.S. Food and Drug Administration (FDA) will consider brexpiprazole to treat agitation in people with Alzheimer’s disease. The supplementary new drug application, submitted by developers Otsuka Pharmaceutical and Lundbeck, has been granted priority review by the FDA, shorting its review time from the standard 10 months…

Treatment with lecanemab (BAN2401), an experimental amyloid-targeting antibody, significantly slowed the progression of dementia symptoms among people with early Alzheimer’s disease in the Phase 3 Clarity AD clinical trial, Biogen and Eisai announced. Both companies, the therapy’s developers, plan to discuss these results with regulatory authorities in the U.S.,…

Trametinib, an oral medication approved to treat certain cancers, improved cognition and neuronal health in a mouse model of Alzheimer’s disease, according to a new study. Data suggest the treatment helped to clear toxic protein aggregates from nerve cells. The study, “MEK1/2 inhibition rescues neurodegeneration by TFEB-mediated activation…

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…