Eisai has completed a rolling submission to the U.S. Food and Drug Administration (FDA) to seek approval for lecanemab (BAN2401), an investigational antibody for the treatment of early Alzheimer’s disease accompanied by beta-amyloid deposits in the brain. The request — made in the form of a biologics license application (BLA) — if accepted by the…
An investigational gamma-secretase modulator designed for the treatment of Alzheimer’s disease led to an efficient and long-lasting reduction of toxic amyloid-beta 42 peptide in cell cultures and mouse brain cells, according to data from a recent study. In mice, the compound, called AC-0027875, was also able to penetrate the brain in high concentrations, which is…
A U.S. Food and Drug Administration (FDA) advisory committee will host a virtual meeting to review a request to expand the approval of Nuplazid (pimavanserin) to include psychosis due to Alzheimer’s disease dementia. The FDA’s Psychopharmacologic Drugs Advisory committee meeting on the application recently submitted by Acadia Pharmaceuticals, which developed and markets Nuplazid, is scheduled for June 17. The committee’s decision…
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 with Alzheimer’s disease enrolled in select clinical trials.…
Higher levels of small high-density lipoprotein (HDL), known as “good cholesterol,” in the fluid surrounding the brain and spinal cord associated with a better performance on cognitive tests in older adults, a study reported. Confirmation of a link between good cholesterol levels and cognitive outcomes in larger groups could lead to new biomarkers of Alzheimer’s disease and…
A Miami Veterans Affairs (VA) clinical site is now part of Longeveron’s Phase 2a clinical trial testing Lomecel-B — an investigational, bone marrow-derived, medicinal signaling cell (MSC) treatment — in patients with mild Alzheimer’s disease. The new clinical site was added following a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans…
The therapeutic candidate allopregnanolone is safe and well-tolerated in people with early Alzheimer’s disease, according to data from a Phase 1b/2a clinical trial that also investigated the medication’s maximum-tolerated dose. Moreover, MRI scans showed that allopregnanolone — dubbed ALLO by researchers — may protect against brain tissue loss in these patients. “Allopregnanolone was well-tolerated and…
Biogen is continuing to actively recruit Alzheimer’s patients for its Phase 4 ICARE AD-US trial, which is evaluating the long-term safety and effectiveness of Aduhelm (aducanumab) in the real-world U.S. clinical setting. Participants — including a targeted enrollment of 16% Latino and African American patients — are currently being enrolled at more than 10 sites in…
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 treatment and to overcome [variation] in…
Biogen has withdrawn its application seeking approval of Aduhelm (aducanumab) to treat early Alzheimer’s disease in the European Union. A committee of the European Medicines Agency (EMA) recommended against approving Aduhelm late last year. Biogen had requested a re-examination of that decision, made by the Committee for Medicinal Products for Human Use (CHMP), but now the…
