From toda’s TMA Medical News Roundup
The New York Times (11/22, Belluck) reports, “Concerns about safety risks of the controversial new Alzheimer’s drug [aducanumab] Aduhelm have intensified in the wake of the death of a 75-year-old woman who experienced brain swelling after receiving infusions of the drug as a participant in a clinical trial.” The incident “occurred in late September,” and “between July and September, three other cases of [amyloid-related imaging abnormalities] ARIA were reported to the F.D.A.’s adverse event database, all requiring hospitalization.”
Bloomberg (11/22, Langreth) reports Biogen’s drug “produced brain swelling in 35% of patients who took the approved dose, although most didn’t experience symptoms, company researchers said in a study” published in JAMA Neurology. The study “found that 362 of 1,029 patients who received the approved dose of the drug experienced the side effect, which showed up in brain imaging of people in two big clinical trials of the drug.”
My take: It’s a good thing that our healthcare system does ongoing monitoring of medication adverse reactions. In this instance, approval of this expensive monoclonal antibody was rushed because Alzheimer’s Disease advocacy groups lobbied heavily for approval despite reservations from the expert panel that reviewed trial data.
This particular adverse effect could/should have been identified during late-phase drug testing before the FDA approved it.