The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.
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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.
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.
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.
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.
By studying centenarians, researchers hope to develop strategies to ward off Alzheimer’s disease and slow brain aging for all of us.
The F.D.A.’s approval of the Alzheimer’s drug aducanumab is inexplicable.
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.”
The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients.
Despite scant evidence that it works, the drug, Aduhelm, is predicted to generate billions of dollars in revenue, much of it from Medicare.
Here’s what you need to know at the end of the day.
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.
An F.D.A. sign-off for aducanumab would make finding a good treatment harder.
Early studies reveal the toll that lockdowns, isolation and stress have taken on those who care for older Americans.
Even short-term exposure to polluted air may impair mental ability in the elderly. Aspirin and other NSAIDs showed some protective effects.
The younger the age at diagnosis for Type 2 diabetes, the higher the risk for Alzheimer’s disease and other forms of dementia years later.
Impulsive purchases, out-of-control spending: These behaviors can be early signs of Alzheimer’s disease or other cognitive decline.
Social medicine programs, which often encourage patients to engage with other people, can help address dementia, isolation and more.
In the narrow window in which patients are aware of their disease, they have sought help in clinical trials. But enrolling enough participants to make these trials count is not easy.
The research, tracking thousands of people from age 50 on, suggests those who sleep six hours or less a night are more likely to develop dementia in their late 70s.
Older people with mild cognitive impairment showed improvements in brain blood flow and memory after a yearlong aerobic exercise program.
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Mediation in the case could force a reopening of hundreds of denied dementia claims from Black players if race-based evaluation benchmarks are thrown out.
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The analysis of nearly 62 million electronic medical records in the U.S. also found that Black people with dementia were at an even greater risk.
A daughter races to collect her father’s memories before Alzheimer’s can steal them away.
“He’s not the old Tony anymore,” his wife, Susan, said. “But when he sings, he’s the old Tony.”
IBM researchers trained artificial intelligence to pick up hints of changes in language ahead of the onset of neurological diseases.
Participants with the disease still declined, but much more slowly than those receiving a placebo, investigators say.
As the vaccine rolls out in nursing homes, more visits should be allowed.
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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 set restrictions to lower risks, but Covid-19 has continued spreading in some homes, and residents are now grappling with consequences from isolation.
As community noise levels increased, so did the risk of Alzheimer’s disease and other forms of dementia.
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A C.D.C. analysis finds that overall death rates have risen, particularly among young adults and people of color.
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Thirteen years ago, my parents tried to wish away my gender transition. Now, Alzheimer’s threatens to erase their memory of me altogether.
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.”
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.
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.
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Coming out repeatedly to my grandmother with Alzheimer’s allowed me to fully embrace my queer identity.