The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.
Tag Archives: Alzheimer’s Disease
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Expert panel says new $56K Alzheimer’s drug is unproven—and worth $8,400 max
Enlarge / The exterior of the headquarters of biotechnology company Biogen in Cambridge, Massachusetts. (credit: Getty | Boston Globe)
Biogen’s new Alzheimer’s drug Aduhelm continues to face opposition after its contentious approval by the Food and Drug Administration last month—which the FDA now says should be independently investigated. Some insurers say they won’t pay for the drug, some hospitals say they won’t administer it, and yet more experts say it has no proven benefit and is dramatically overpriced at $56,000 for a year’s supply.
On Thursday, a panel of medical experts convened by the nonprofit Institute for Clinical and Economic Review (ICER) voted 15 to 0 to say that there is no evidence that Aduhelm provides clinical benefit to patients. The unanimous vote echoes another one from a panel of expert advisors for the Food and Drug Administration who voted last November against FDA approval. Eleven of ten advisors voted that data collected in two identical Phase III clinical trials failed to show that the drug is effective, with the remaining advisor voting “uncertain.”
The FDA nevertheless approved the drug on June 7, sparking a firestorm of criticism. In an unprecedented move last week, the FDA updated its recommendation for who should receive the drug, significantly narrowing the pool from all Alzheimer’s patients to only those with mild disease. It’s unusual for the FDA to make such a modification so soon after an initial decision and without fresh data to back a change.
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F.D.A. Requests Investigation of Its Own Alzheimer’s Drug Approval
The agency’s acting head said a federal review should look into whether any interactions between agency staff and the drug developer, Biogen, broke F.D.A. rules.
In a Reversal, F.D.A. Calls for Limits on Who Gets Alzheimer’s Drug
The agency faced criticism for approving Aduhelm for all Alzheimer’s patients. The new label recommends that the drug be given only to patients with mild symptoms.
Many Alzheimer’s Experts Say Use of Aduhelm Should Be Sharply Limited
Even those who supported the F.D.A.’s approval of the controversial new drug said authorizing it for anyone with Alzheimer’s disease was much too broad.
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The F.D.A.’s Approval of Biogen’s Alzheimer’s Drug Is a New Low
The F.D.A.’s approval of the Alzheimer’s drug aducanumab is inexplicable.
Three experts resign as FDA advisors over approval of Alzheimer’s drug
Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly)
Fallout continues from the Food and Drug Administration’s contentious decision this week to approve Biogen’s Alzheimer’s drug Aduhelm (aducanumab) despite a lack of efficacy data.
Three experts who sat on an advisory committee for the FDA have now resigned over the decision.
The advisory committee reviewed the data behind Aduhelm last November and voted overwhelmingly against approval. Of the 11 advisors on the committee, 10 voted “no” on the question of whether Biogen had collected enough evidence to indicate that the drug is effective. The remaining advisor voted “uncertain.”
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Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug
The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients.
Alzheimer’s Drug Is Bonanza for Biogen, Most Likely at Taxpayer Expense
Despite scant evidence that it works, the drug, Aduhelm, is predicted to generate billions of dollars in revenue, much of it from Medicare.
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Alzheimer’s Drug Poses a Dilemma for the F.D.A.
If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say there isn’t enough evidence it works.
People Want an Alzheimer’s Drug. Aducanumab Isn’t the One.
An F.D.A. sign-off for aducanumab would make finding a good treatment harder.
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Doctors Harness the Power of Human Connections
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They Have Alzheimer’s. This Clinical Trial May Be a Last Hope.
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Sleeping Too Little in Middle-Age May Raise Dementia Risk, Study Finds
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Walking and Other Aerobic Exercise May Aid the Aging Brain
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Learning to Love a Stepmother Through the Language of Flowers
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NFL’s Concussion Settlement Will Look at Racial Bias in Payouts
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How Pandemic Isolation Affected an Alzheimer’s Patient in a Nursing Home
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A Year of Unraveling
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Marty Schottenheimer, 77, Winning N.F.L. Coach With Four Teams, Dies
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Study Finds People With Dementia Are Twice as Likely to Get Covid
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Modern Love: The Day His Journal Went Blank
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Tony Bennett Reveals He Has Alzheimer’s Disease
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Alzheimer’s Prediction May Be Found in Writing Tests
IBM researchers trained artificial intelligence to pick up hints of changes in language ahead of the onset of neurological diseases.
Eli Lilly’s Alzheimer’s Drug Shows Promise in Small Trial
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Nursing Home Patients Are Dying of Loneliness
As the vaccine rolls out in nursing homes, more visits should be allowed.
Alzheimer’s Researchers Study a Rare Brain
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Singing My Dad Back to Me
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Controversial Alzheimer’s Drug Faces Critical Test Before F.D.A. Panel
If ultimately approved, the drug, aducanumab, made by Biogen, would be the first new Alzheimer’s treatment in nearly two decades. Some evidence suggests it slows, but does not stop, cognitive decline.
Nursing Homes, Racked by the Virus, Face a New Crisis: Isolation
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Living in Noisy Neighborhoods May Raise Your Dementia Risk
As community noise levels increased, so did the risk of Alzheimer’s disease and other forms of dementia.
Why Are TikTok Teens Listening to an Album About Dementia?
Creepypasta meets esoterica in an ongoing meme.
The Pandemic’s Real Toll? 300,000 Deaths, and It’s Not Just From the Coronavirus
A C.D.C. analysis finds that overall death rates have risen, particularly among young adults and people of color.
Having Dementia Doesn’t Mean You Can’t Vote
Yes, you can help a cognitively impaired person participate in the election. But heed these two guidelines.
Will They See Me as a Son, a Daughter or a Stranger?
Thirteen years ago, my parents tried to wish away my gender transition. Now, Alzheimer’s threatens to erase their memory of me altogether.
Judge Agrees to Retire After Alzheimer’s Diagnosis
Judge ShawnDya L. Simpson, 54, agreed to step down after the Commission on Judicial Conduct determined her behavior in court was “erratic and at times intemperate.”
Dementia on the Retreat in the U.S. and Europe
Rates of dementia have steadily fallen over the past 25 years, a new study finds. But the disease is increasingly common in some parts of the world.
‘Amazing, Isn’t It?’ Long Sought Blood Test for Alzheimer’s in Reach
Scientists say such tests could be available in a few years, speeding research for treatments and providing a diagnosis for dementia patients who want to know if they have Alzheimer’s disease.
Trump Says He ‘Aced’ a Cognitive Test. What Does That Really Mean?
Experts say one popular test that the president might have taken is by no means definitive, or even diagnostic.
I Miss My Father’s Mind
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Pride Through Repetition
Coming out repeatedly to my grandmother with Alzheimer’s allowed me to fully embrace my queer identity.