Biogen's Aduhelm label far exceeds clinical trial population, study says. That could bring real-world surprises

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.