FDA Narrows Prescribing Guidance For Controversial Alzheimer’s Drug
After fierce criticism of its accelerated approval for Biogen's pricey Alzheimer's medication Aduhelm, the Food and Drug Administration is reversing its broad recommendation and now saying the treatment should only be prescribed to patients with milder symptoms.
Stat:
FDA Revises Prescribing Information For Biogen's Alzheimer's Drug
The Food and Drug Administration on Thursday changed the prescribing label for Biogen’s Alzheimer’s treatment Aduhelm — narrowing its recommended use to patients with milder forms of the disease. Biogen and the FDA described the Aduhelm label update as a clarification meant to better reflect data from clinical trials. But changing the label so soon will be seen as the FDA yielding to outside criticism that the drug’s approval — just one month ago — was overly permissive. (Feuerstein, 7/8)
The New York Times:
In Reversal, F.D.A. Calls For Limits On Who Gets Alzheimer’s Drug
Under fire for approving a questionable drug for all Alzheimer’s patients, the Food and Drug Administration on Thursday greatly narrowed its previous recommendation and is now suggesting that only those with mild memory or thinking problems should receive it. The reversal, highly unusual for a drug that has been available for only a few weeks, is likely to reduce the approximate number of Americans who are eligible for the treatment to 1.5 million from six million. (Robbins and Belluck, 7/8)
The Boston Globe:
FDA Narrows Recommended Use Of Biogen Alzheimer’s Therapy After Flood Of Criticism
The US Food and Drug Administration, which approved Biogen’s controversial new drug for Alzheimer’s disease despite scant evidence that it works, narrowed its recommended use of the medicine on Thursday to patients with early symptoms, citing “confusion regarding the intended population for treatment.” Biogen had already said Aduhelm was meant for Alzheimer’s patients with mild cognitive impairment, the group studied by the Cambridge drug maker in three clinical trials. But the FDA didn’t limit the medication to those people, who number 1 to 2 million in the United States, when it approved Aduhelm on June 7, raising the specter that anyone diagnosed with the disease — an estimated 6 million Americans — might seek it. (Saltzman and Gardizy, 7/8)
Also —
Stat:
FDA’s Expansive Aduhelm Approval Surprised Even Top Agency Officials
The Food and Drug Administration’s contentious decision to approve a new Alzheimer’s drug for every single patient with the disease surprised even top FDA officials involved in deliberations about the approval process, two senior staffers told STAT. One of the sources went further, saying they would never have supported the faster approval process that the FDA employed had they known the agency was considering such a broad patient population. (Florko, Silverman, Cohrs and Garde, 7/8)
The New York Times:
A New Alzheimer’s Drug Offers More Questions Than Answers
Dr. Kenneth Koncilja, a geriatrician at the Cleveland Clinic, saw the announcement from the Food and Drug Administration on June 7, on Twitter: The agency had approved Aduhelm (aducanumab), the first drug to treat Alzheimer’s disease to be approved in nearly 20 years. The calls from patients’ spouses and family members began within the hour, and have not stopped. “I was shocked at how fast the word spread — ‘Hey, is this something we can use? When can we get it?’” Dr. Koncilja recalled. “There’s a mix of excitement, anxiety and desperation.” (Span, 7/8)
KHN:
Doctors Weigh Pros And Cons Of Prescribing Hot-Button Alzheimer’s Drug
As physicians and health policy experts debate the merits of Aduhelm, the first new drug for Alzheimer’s disease approved in 18 years, patients want to know: “Will this medication help me — and how much?” Doctors explaining the pros and cons of Aduhelm won’t have a definitive answer. “On an individual basis, it will be absolutely impossible to predict,” said Dr. Allan Levey, director of the Goizueta Alzheimer’s Disease Research Center at Emory University. (Graham, 7/9)
In related news about dementia —
CNN:
Flossing Your Teeth May Protect Against Cognitive Decline, Research Shows
Flossing your teeth isn't just important for keeping your dentist happy -- it may also protect against cognitive decline. Good oral health habits like brushing and flossing may prevent cognitive impairment and dementia, according to a new analysis led by researchers at NYU Rory Meyers College of Nursing. "Given the staggering number of people diagnosed with Alzheimer's disease and dementia each year, and the opportunity to improve oral health across the life span, it's important to gain a deeper understanding of the connection between poor oral health and cognitive decline," said Bei Wu, a professor in global health at NYU Rory Meyers College of Nursing and the senior study author, in a statement. (Kent, 7/8)
