FDA Approval of Aducanumab
What You Should Know
On June 7, the FDA approved aducanumab (trade name ADUHELM) for use in Alzheimer’s disease. This is a historic milestone. The last drug approval for Alzheimer’s disease happened 18 years ago. The FDA decision today brings new hope to families with Alzheimer’s disease. However, this was a controversial decision.
ADUHELM was developed to remove amyloid from the brain. It performs that function extremely well. Nonetheless, the evidence that ADUHELM offers clinical improvement or that it slows clinical worsening is not totally convincing. The FDA took a chance with this decision. Now that the drug is approved, we hope that the additional data coming out of patients on ADUHELM will surprise us on the upside and prove that the drug has a meaningful clinical impact.
Even under the best circumstances, ADUHELM is not a cure. There is no claim that it reverses existing disease or that it stops progression. ADUHELM requires monthly intravenous infusions, can have side effects that require monitoring by periodic brain scans, and it is likely to be very expensive. Our job as health care providers is to explain these factors as plainly as possible to our patients and families and involve them in decision making.
— Marsel Mesulam, MD
Director of the Mesulam Center for Cognitive Neurology and Alzheimer's Disease
Chief of Behavioral Neurology in the Department of Neurology, Ruth Dunbar Davee Professor of Neuroscience