Lecanemab (BAN2401), an amyloid-targeted antibody therapy for early Alzheimer’s disease, has been granted priority review in Japan, according to Eisai and Biogen, its developers. Priority review, as designated by the Japanese Ministry of Health, Labour and Welfare (MHLW), shortens the review period of applications seeking approval…
The U.S. Food and Drug Administration (FDA) has rejected Eli Lilly’s application for the accelerated approval of its amyloid-clearing antibody donanemab for treating Alzheimer’s disease. An accelerated approval lets the FDA grant conditional marketing authorization for a treatment based on preliminary safety and efficacy data, but additional clinical…
Soleo Health was selected by Eisai as the sole specialty pharmacy to carry Leqembi (lecanemab) for Alzheimer’s disease patients prescribed the treatment. Leqembi, approved for use in the U.S. earlier this month, is an anti-amyloid targeted antibody, used to treat mild cognitive impairment or mild dementia due to Alzheimer’s.
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…
Note: This story was updated Feb. 7, 2023, to correct the number of participants in the Study 201 (NCT01767311), which evaluated Leqembi in 856 people with early Alzheimer’s. Lecanemab (BAN2401), Eisai and Biogen’s amyloid-targeted antibody therapy, has earned approval — under an accelerated approval pathway — from the U.S.
The U.S. Food and Drug Administration (FDA) has cleared for use tests designed by Roche to measure the levels of two Alzheimer’s disease biomarkers — beta-amyloid and phosphorylated tau — in cerebrospinal fluid (CSF), the fluid surrounding the brain and spinal cord. Roche reported that these assays, which will…
AB Science is initiating a Phase 3 trial to evaluate the safety and efficacy of its candidate therapy masitinib in patients with mild to moderate Alzheimer’s disease. The company has received approval for this study from the U.S. Food and Drug Administration (FDA), as well as authorities in…
INmune Bio received the green light for MINDFul, its Phase 2 trial of XPro1595 — an experimental treatment for Alzheimer’s disease — to begin in Canada. Health Canada, Canada’s regulatory health authority, issued a “no objection letter” where it gives the company official permission to test XPro1595 in…
About 1.5 years of treatment with lecanemab (BAN2401) — now under regulatory review in the U.S. — was found to significantly slow the progression of dementia symptoms in people with early-onset Alzheimer’s disease. That’s according to just-released full data from the Phase 3 Clarity AD clinical trial, which showed…
Note: The headline of this story was updated Dec. 1, 2022, to correct that the decision to continue the Phase 2/3 clinical trial of fosgonimeton was recommended by an independent data monitoring committee. A Phase 2/3 clinical trial evaluating Athira Pharma’s experimental therapy fosgonimeton (formerly ATH-1017) in people…
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