Author Archives: Marisa Wexler MS

Aduhelm Most Appropriate for Early-stage Alzheimer’s, Experts Say

Aduhelm (aducanumab), approved for Alzheimer’s disease in the U.S., is most appropriate for people with mild cognitive impairment (MCI) due to the disease or early Alzheimer’s dementia, the disorders for which it was tested in clinical trials and subsequently approved, according to experts from the scientific community. The experts…

FDA Approves Aduhelm, First Targeted Alzheimer’s Therapy

For the first time in almost 18 years, the U.S. Food and Drug Administration (FDA) has approved a new treatment — Aduhelm, also known as aducanumab — for Alzheimer’s disease, and a first targeted treatment for patients. With this approval, Aduhelm becomes the first disease-modifying therapy for Alzheimer’s, and…

FDA Places Gene Therapy LX1001 on Fast Track

LX1001, a gene therapy for Alzheimer’s disease being developed by Lexeo Therapeutics, has been granted fast track designation by the U.S. Food and Drug Administration (FDA). The therapy is designed to deliver a version of the APOE gene, called APOE2, to cells in the central nervous system (the…

#AANAM – EMBARK Trial to Again Test Safety, Efficacy of Aducanumab

A new Phase 3 clinical trial, called EMBARK, will evaluate the long-term safety and efficacy of aducanumab (BIIB037), an investigational therapy for Alzheimer’s disease in patients who took part in its previous clinical studies. The trial’s design was described by Carmen Castrillo-Viguera, a medical director at Biogen, in the poster “…

Aduhelm Approved