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The U.S. Food and Drug Administration (FDA) has approved Eli Lilly‘s antibody therapy donanemab, now Kisunla, for certain adults with Alzheimer’s disease. Specifically, Kisunla is indicated for patients with early symptomatic Alzheimer’s — to include individuals with mild cognitive impairment or mild dementia, and confirmed evidence of…

The safety and effectiveness of oral therapy candidate buntanetap are comparable in people with early Alzheimer’s disease regardless of whether they do or do not carry a genetic risk factor known as APOE4. That’s according to new data from a Phase 2/3 clinical trial (NCT05686044) that tested…

Note: This story was updated June 21, 2024, to correct that SNK01 was given approval by NKGen Biotech’s Safety Review Committee. SNK01, a natural killer (NK) cell therapy being developed by NKGen Biotech, has received clearance from its Safety Review Committee to advance into the Phase 2 part of a…

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…