FDA OKs First New Alzheimer’s Drug In Nearly 20 Years In Hotly Debated Move

Stat: FDA Grants Historic Approval To Alzheimer’s Drug From Biogen
The Food and Drug Administration on Monday approved the first new treatment for Alzheimer’s disease in nearly two decades, a landmark decision that has been eagerly awaited by millions of Americans diagnosed with the condition but that will be hotly contested by some in the scientific community who doubt the drug’s effectiveness. While other drugs treat symptoms of Alzheimer’s, the new medicine, called Aduhelm, is the first to attack what some believe is an underlying cause of the disease and slow cognitive decline, albeit marginally. (Feuerstein and Garde, 6/7)

AP: FDA Approves Much-Debated Alzheimer’s Drug Panned By Experts
It’s the only therapy that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia. The decision, which could impact millions of Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits. (Perrone, 6/7)

The Washington Post: FDA Approves First Drug Intended To Slow Cognitive Decline Caused By Alzheimer’s Disease 
But in an explicit acknowledgment of the uncertainties about the effectiveness of the drug, the FDA did not grant the medication full approval. Instead, the agency cleared the drug — its brand name will be Aduhelm — based on its ability to reduce clumps of amyloid beta in the brain, a hallmark of the disease. It ordered the drug’s maker, the biotech giant Biogen, to conduct a post-approval study confirming the medicine actually slows cognitive deterioration. If the medication does not provide such a clinical benefit, the FDA’s approval could be withdrawn. (McGinley, 6/7)

ABC News: New Alzheimer’s Drug Is 1st Of Its Kind To Be FDA Approved 
The FDA will require Biogen to conduct a new, large clinical trial to determine the drug's benefit, and reserves the right to rescind the approval in the future. Meanwhile, patients will have access to the drug, which is given by intravenous infusion. (Ramanathan and Salzman, 6/7)

Stat: FAQs: What You Need To Know About The Alzheimer’s Drug Aduhelm
The Food and Drug Administration on Monday approved Biogen’s new Alzheimer’s drug, a decision with far-reaching implications for patients, clinicians, and others. Here’s a rundown on some basic questions and answers about the drug, known as Aduhelm. (Cooney, 6/7)

Also —

Stat: A Twist In FDA’s Alzheimer’s Decision: No Limits On Which Patients Can Get It 
As if the saga of aducanumab needed another twist, the Food and Drug Administration tossed in an extra curveball Monday as it approved the Alzheimer’s therapy by specifying who would be eligible for the treatment. Or rather, not specifying. Doctors had anticipated that if the FDA gave the green light to the therapy now called Aduhelm, it would endorse its use for patients like those who qualified for clinical trials: people in the earliest stages of Alzheimer’s disease, who also had the plaques of amyloid protein that the therapy aims to clear. (Joseph, 6/7)

Stat: Aduhelm Trial Participants Reflect On Their Complicated Reactions To Approval
For the roughly 3,500 people who volunteered as clinical trial participants for the Alzheimer’s therapy Aduhelm, Monday’s divisive approval spurred a complicated brew of emotions. There was elation, yes — that the endorsement of the therapy by the Food and Drug Administration was a validation that maybe it really had been working for them, that it was letting them take the dog for a walk, or embrace new projects, or have a simple conversation with their spouse for more years than they could have otherwise. (Joseph, 6/8)