Opening Blood-Brain Barrier to Deliver Alzheimer’s Drug Shows Promise
Aducanumab (Aduhelm) infusions combined with focused ultrasound led to lower cerebral amyloid-beta levels in Alzheimer’s disease, a proof-of-concept trial showed. The investigational treatment involved creating an opening in the blood-brain barrier with MRI-guided focused ultrasound to boost drug delivery. In each of three participants who received aducanumab infusions, amyloid reduction was greater in brain regions […]
Congressional Probe of Alzheimer’s Drug Approval Finds Fault With FDA Actions
The FDA broke with its own protocols in reviewing and subsequently approving Alzheimer’s drug aducanumab (Aduhelm), by inappropriately collaborating with drugmaker Biogen on briefing documents, holding unreported meetings, and failing to gain internal consensus before engaging in such collaborations, according to an in-depth congressional investigation of the interactions between the agency and the drugmaker. The […]
Aducanumab Data Finally Published, but Alzheimer’s Experts Spot Problems
The long-awaited results of the twin phase III trials for aducanumab (Aduhelm), the controversial drug approved last year for early Alzheimer’s disease, were published in the Journal of Prevention of Alzheimer’s Disease (JPAD), a journal whose editor-in-chief is aducanumab researcher and study co-author Paul Aisen, MD, of the University of Southern California in Los Angeles. […]
Aducanumab: What to Know if You Prescribe
Not all physicians who treat Alzheimer’s disease will prescribe the new Alzheimer’s drug aducanumab (Aduhelm) — major hospital systems like the Cleveland Clinic and Mount Sinai in New York City, for example, won’t administer the controversial treatment — but those who will offer the drug need more information about how to use it, a panel […]
To Pay or Not to Pay: Medicare’s Big Aduhelm Decision
In June, the FDA approved aducanumab (Aduhelm) to treat patients with Alzheimer’s disease using the agency’s accelerated approval pathway, despite significant concerns about the evidence regarding the drug’s safety and effectiveness. The agency’s approval decision contradicted the recommendations of its own advisory committee, which voted overwhelmingly against the evidence presented in support of the drug. […]
Alzheimer’s Aducanumab Prescribing Information Changes
Just a month after it gave the new Alzheimer’s drug aducanumab (Aduhelm) the green light, the FDA decided to change the label. The agency approved an updated label narrowing who should receive the drug, stating that aducanumab should be initiated in Alzheimer’s patients with “mild cognitive impairment or mild dementia stage of disease, the population […]