FDA Fast-Tracked New Alzheimer’s Treatment to Mixed Reviews

Alzheimer’s is a debilitating brain disorder affecting memory and, eventually, language, reasoning, and social behavior. Diagnosed in nearly 6.2 million Americans, Alzheimer’s is a progressive, irreversible disease with treatments mainly focusing on symptoms, such as delaying memory loss, and not the underlying cause—that is, until now.

In June of 2021—just in time for Alzheimer’s Awareness Month—the U.S. Food and Drug Administration (FDA) approved the first Alzheimer’s treatment since 2003, Aduhelm (Aducanumab): a first-of-its-kind treatment that targets the underlying cause of the neurodegenerative disease. Removing protein clumps in the brain, Aduhelm partially removes what some researchers believe may be the root cause of Alzheimer’s, and therefore, may help to prevent Alzheimer’s altogether. The approval came using the FDA’s accelerated approval pathway, which expedites the process based on the premise the drug has shown potential to provide a significantly different or wholly new treatment for a serious or life-threatening illness.

Its approval, however, has sparked controversy.

While the FDA defends Aduhelm’s efficacy and well-warranted approval, citing the drug is the first to show significant progress in reducing one of the hallmarks of Alzheimer’s: brain plaques called beta-amyloids that build up in an Alzheimer’s patient’s brain.  Some researchers are calling into question the drug’s approval, claiming  it did not definitively demonstrate its ability to slow cognitive decline during clinical trials. In July, two major medical centers, The Cleveland Clinic and Mount Sinai, said they would not administer the new drug citing concerns over current data on its safety and efficacy.

For some, the drug’s approval is a sign of hope that better, more effective treatments are indeed possible and on the way. For others, it is the opposite, as they fear rapid approval leaves too much room for error, stunting research efforts and ultimately, not allow patients to get the life-saving treatments they need.

PBWS Law recognizes the severity of Alzheimer’s disease and the devastating effects it can have on both individuals and their loved ones. Our goal is to help secure the things which matter most and preserve the life you have worked so hard to achieve. Whether by working with you to craft a will, trust, or implement other elements of an estate plan—our team of attorneys are here for you.

Updated July 15, 2021

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Alzheimer’s & Brain Awareness Month | Alzheimer’s Association

FDA Grants Accelerated Approval for Alzheimer’s Drug | FDA

Landmark Alzheimer’s drug approval confounds research community (nature.com)

Wills & Trusts – Albuquerque & Santa Fe Attorneys | PBWS (pbwslaw.com)