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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…

DISCERN, a biomarker test reported to accurately diagnose Alzheimer’s disease at its earliest stages, routinely would be used by 90% of physicians who responded to a recent survey. With a positive test using a small skin sample, physicians were some six times more likely to diagnose Alzheimer’s and nearly three times…

The Phase 1 INTERCEPT-AD trial testing the investigational antibody ACU193 in patients with early Alzheimer’s disease has now completed enrollment, according to its developer, Acumen Pharmaceuticals. Top-line results, including safety and proof-of-concept mechanism data, are expected ahead of schedule in the third quarter of this year. “Today’s…

Dosing has begun in a first group of healthy adults in a Phase 1a clinical trial of OLX-07010, Oligomerix’s lead treatment candidate for Alzheimer’s disease and other neurodegenerative disorders. OLX-07010 is an oral small molecule inhibitor of tau self-association — one of the initial steps leading to tau…

A low dose of ACI-24.060, AC Immune’s investigational vaccine therapy, safely elicited the production of anti-amyloid beta antibodies among patients with Alzheimer’s disease, according to an interim analysis of a Phase 1b/2 trial. The study, called ABATE (NCT05462106), is evaluating the vaccine’s safety and ability to provoke…

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.