The Controversy Over the FDA's Approval of The First Alzheimer’s Treatment Keeps Growing

More importantly for patients and their families, the approval, and rollout of aducanumab, may muddle Alzheimer’s treatment in unproductive ways. The drug has only been studied in people with the earliest signs of Alzheimer’s dementia, but in its approval, the FDA did not limit use of the drug to this population.

6 ways the FDA’s approval of Aduhelm does more harm than good

Like many people, I was shocked when the Food and Drug Administration ignored the advice of its neurological drugs advisory panel and broadly approved Biogen’s new drug, Aduhelm, even for populations never included in the clinical trials to assess the drug.

A New Alzheimer’s Drug Offers More Questions Than Answers

The approval of Aduhelm to treat Alzheimer’s disease has raised hope among older adults, but many doctors wonder if it is warranted.

Bad medicine: aducanumab is a lackluster drug with a high price tag

Controversy has swirled around aducanumab, an experimental drug developed by Biogen, long before the FDA approved it on Monday to treat early-stage Alzheimer’s disease. The agency now finds itself under scrutiny in a situation with no good outcome. There were defensible arguments for approval, one of which is that until now there has been no disease-altering therapy to offer to individuals with Alzheimer’s or their families.

By approving Biogen’s Alzheimer’s drug, the FDA is shifting its rules. That is a giant risk

In order to approve a new Alzheimer’s treatment, the Food and Drug Administration is rewriting its rulebook, an enormously risky move that could accelerate the public’s access to medicines but upend the future of drug regulation, forcing the 114-year-old agency to do the equivalent of redesigning a fighter plane in mid-flight.

FDA approval of controversial Alzheimer’s drug could delay discovery of more promising treatments

The amyloid cascade, the idea behind how aducanumab works, is the subject of great controversy in the scientific community. This hypothesis has dominated for nearly 30 years and guided the search for treatments that aim to remove amyloid from the brain. Yet every clinical trial using this approach has failed, representing dozens of products and hundreds of billions of dollars in investment.

How the new Alzheimer’s drug works—and why the FDA is under fire for approving it

The first drug approved for the disease in 18 years, Aduhelm shows only scant benefit in clinical trials, and experts debate whether it even has the right biological target.

If the FDA approves Biogen’s Alzheimer’s treatment, I won’t prescribe it

Most visits to the memory center where I care for individuals living with Alzheimer’s disease end in disappointment. “Are there any new treatments, Dr. Karlawish?” patients or family members hopefully ask. I shake my head and say, “No.”

New Alzheimer’s Drug: What Doctors Want You to Know About Aduhelm

How does the new treatment work, and why is it controversial? Here’s what patients and their caregivers should know.

The Attack on an Alzheimer’s Drug

Public-health and media critics failed to stop federal approval of Aduhelm, Biogen’s new drug for Alzheimer’s. So now they’re mounting an assault on the drug’s cost to stop Medicare from paying for it. Their sudden and rare concern for the federal fisc is illuminating, and not in a good way.

The F.D.A.'s Extraordinary Approval of a Questionable Treatment for Alzheimer's

The initial data on aducanumab’s ability to slow Alzheimer’s patients’ cognitive decline was so poor that, in 2019, Biogen halted its clinical trials.

The FDA Is a Melting Iceberg

The byzantine world of pharmaceutical regulation has recently broken into the public consciousness, causing a bit of a panic. Aducanumab—the first new Alzheimer’s treatment in nearly two decades—was approved by the Food and Drug Administration on June 7 despite scant evidence of benefit, and against the nearly unanimous advice of the agency’s expert advisers. Op-eds called the decision, which could trigger billions of dollars in new government spending, a “false hope,” “bad medicine,” and “a new low.”

The harrowing new reality for Alzheimer’s patients

Alzheimer’s patients and families live in a cloud of uncertainty. It’s about to get worse.

The new Alzheimer’s drug is the first of its kind. Will it be the last?

The FDA’s controversial approval of a Biogen drug for Alzheimer’s disease could blunt future R&D, experts warn.

Toxic Tau Of Alzheimer's May Offer A Path To Treatment

"Many people focused on amyloid beta for many years," says Julia Gerson, a graduate student in neuroscience at the University of Texas Medical Branch, who presented a paper on tau at the neuroscience meeting. "Now it's coming out that tau might be more important."

Why the Approval of That Alzheimer’s Drug Is So Disturbing

Drugs that merely fiddle with the body’s physiology provide a false sense of control—at a cost.