Abstract and Introduction
The US Food and Drug Administration (FDA) sparked quite a controversy in June when it bestowed marketing approval on Biogen's Aduhelm (aducanumab) for the treatment of Alzheimer disease. Aduhelm is the first therapy to target the underlying disease process of Alzheimer by reducing amyloid beta plaque in the brain, a hallmark of the disease.
Indeed, many experts remain divided on the drug's efficacy and disagree over whether it should have received FDA approval. There are also issues surrounding insurance coverage for the treatment. (see online sidebar).
At the same time, however, the FDA's decision has shone a spotlight on the important role that neuroradiologists and modalities like positron emission tomography (PET) and magnetic resonance imaging (MRI) play in the diagnosis and treatment of neurodegenerative diseases, as well as in the study of new treatments like aducanumab.
"Aduhelm will increase the need for structural imaging for safety monitoring," says Michael Weiner, MD, a professor in residence of radiology and biomedical imaging, medicine, psychiatry, and neurology at the University of California, San Francisco.
"PET detects amyloid and tau, [and] amyloid PET is often used as an inclusion criterion and to show plaque removal and will likely be needed to identify people for treatment with Aduhelm," explains Dr Weiner, who is also principal investigator of the Alzheimer's Disease Neuroimaging Initiative, the world's largest observational study of patients with Alzheimer disease.
Tina Young Poussaint, MD, FACR, president of the American Society of Neuroradiology (ASNR), and a professor of radiology at Harvard Medical School, agrees.
"Whether it is Alzheimer's disease or other dementias, there will be a change in the number of imaging studies for both PET and MRI, which are used to monitor the impact of treatments with Aduhelm, says Dr Poussaint, who also a neuroradiologist and the Lionel W Young Chair in Radiology at Boston Children's Hospital.
Appl Radiol. 2021;50(5):37-39. © 2021 Anderson Publishing, Ltd.