The U.S. Food and Drug Administration (FDA) has agreed to review a supplemental application seeking authorization of once-monthly maintenance dosing for Leqembi (lecanemab), an approved treatment for early Alzheimer’s disease. A decision from the agency is expected by Jan. 25, 2025, according to a press release from…
An advisory committee to the U.S. Food and Drug Administration (FDA) has unanimously voted in favor of donanemab, an anti-amyloid therapy developed by Eli Lilly that’s currently up for approval as a treatment for early Alzheimer’s disease. All members of the FDA’s Peripheral and Central…
There’s lots of ways to support Alzheimer’s and Brain Awareness Month this month, from “going purple” to sharing facts and resources, to help call attention to the estimated 47 million people globally who live with Alzheimer’s disease or dementia. Alzheimer’s is the most common cause of…
Treatment with buntanetap, a small molecule being developed by Annovis Bio for neurodegenerative diseases, improved cognitive function in people with mild Alzheimer’s positive for certain disease biomarkers, especially in earlier stages of the disease. These are findings from a Phase 2/3 clinical study (NCT05686044) in which 353…
Otsuka Pharmaceutical has stopped the development of AVP-786, an investigational oral therapy to treat agitation in people with Alzheimer’s disease. The decision comes after the company’s recent announcement that the treatment failed to meet its primary efficacy goal of lowering agitation in ALS patients after 12…
Eisai has started a rolling application seeking U.S. approval of a subcutaneous, or under-the-skin, injection version of Leqembi (lecanemab) for maintenance dosing in people with early Alzheimer’s disease. This formulation of the approved intravenous (into-the-vein) medication is expected to reduce the treatment burden for patients, if granted…
A U.S. Food and Drug Administration (FDA) advisory committee will meet June 10 to review clinical trial data related to donanemab, Eli Lilly‘s experimental anti-amyloid therapy, according to a company press release. The FDA is reviewing Lilly’s application seeking approval of donanemab to treat early Alzheimer’s…
The U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to Elecsys Phospho-Tau 217 (pTau217), a blood-based biomarker test that can help distinguish Alzheimer’s disease from other neurodegenerative disorders. The test, developed by Roche in collaboration with Eli Lilly, is intended to support a more accurate…
BioXcel Therapeutics plans to launch a pivotal Phase 3 in-care trial — one involving patients in nursing or assisted living facilities — to continue to evaluate BXCL501 (dexmedetomidine sublingual film) for the acute treatment of agitation in patients with Alzheimer’s disease dementia. BXCL501 is an experimental orally dissolving…
Treatment with SNK01, a natural killer (NK) cell therapy being developed by NKGen Biotech, appears safe and well tolerated and may offer a cognitive benefit to people with Alzheimer’s disease, according to data from a small Phase 1 clinical trial. Given directly into the bloodstream, SNK01 was able…
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