Study: Fewer than 1% of geriatric patients with cognitive complaints met Aduhelm research trial criteria. What can we expect about its real-world safety?

Biogen’s Aduhelm label far exceeds clinical trial population, study says. That could bring real-world surprises (Fierce Pharma): While the chatter surrounding Biogen’s controversial Alzheimer’s med Aduhelm has largely been centered on a pivotal Medicare reimbursement decision as of late, analysts are pointing to one new study that suggests there may be “room for surprises” when it comes to the treatment’s safety. In a note to clients on Wednesday, RBC Capital Markets analysts highlighted a recent study that applied Biogen’s publicly disclosed clinical trial inclusion criteria for Aduhelm to 911 patients in a geriatric outpatient unit at a hospital in Milan, Italy. Researchers determined that only six patients, or less than 1% of those evaluated, would have qualified for the treatment’s clinical trials—known as Emerge and Engage—ahead of the FDA’s historic approval in June, according to a letter published in the Journal of the American Geriatrics Society in late July. To the RBC analysts, this suggests that there’s room for previously undetected side effects for the infusion once it’s administered to thousands of patients beyond those who were represented in the clinical trials, according to the note … This could affect Aduhelm’s “narrative and ultimate launch curve, not to mention potential reimbursement breadth,” the analysts said. The Analysis: “Real world” eligibility for aducanumab (Journal of the American Geriatrics Society): To iden...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Brain/ Mental Health aducanumab Aduhelm Alzheimer's med American Geriatrics Society Biogen cognitive cognitive complaints FDA Medicare reimbursement undetected side effects Source Type: blogs