Aduhelm

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After Aduhelm Debacle, New Alzheimer's Drug Emerges

Biogen, partner Eisai: Clinical trial for lecanemab shows promising 27% slowing of cognitive decline

(Newser) - Last year, the FDA approved aducanumab , marketed as Aduhelm , a controversial drug made by Biogen and its Japanese partner Eisai to treat Alzheimer's. Things didn't go well, though, with expert opposition to the costly medication and a final death blow to its place in the market after Medicare...

Medicare Makes Big Decision on New Alzheimer's Drug

For now, it will limit Aduhelm coverage to those involved in a clinical trial

(Newser) - Medicare said Tuesday it will limit coverage of a $28,000-a-year Alzheimer’s drug whose benefits have been widely questioned , a major development in the nation’s tug-of-war over the fair value of new medicines that offer tantalizing possibilities but come with prohibitive prices. The initial determination from the Centers...

Death Raises New Concern Over Alzheimer's Drug

Critics say Aduhelm approval was rushed

(Newser) - Aduhelm, the Alzheimer’s drug approved this summer in a process that led some FDA advisers to quit , is the subject of new controversy. A 75-year-old woman in Canada participating in a clinical trial died in September after going to the hospital for a seizure, the New York Times reports....

2 Health Care Systems Won't Use Aduhelm Yet

Cleveland Clinic, Mount Sinai wait for results of investigation into FDA approval process

(Newser) - Although a new drug for treating Alzheimer's cleared the Food and Drug Administration's approval process, a pair of large health systems say it has not cleared theirs. The Cleveland Clinic and Mount Sinai Health System in New York won't administer Aduhelm to patients until they have more...

FDA Walks Back Broad Alzheimer's Drug Advice

After criticism, agency says label will limit candidates to those with mild symptoms

(Newser) - After being widely criticized for approving the use of a new drug to treat all Alzheimer's patients, despite only limited evidence that it works, the Food and Drug Administration has stepped back from that decision. The agency announced its new instructions Thursday that say Aduhelm is intended only for...

New Alzheimer's Drug Spurs Big Concerns, an Investigation

2 House committees launch inquiry into approval, cost of Biogen's Aduhelm

(Newser) - It was supposed to have been a "cause for celebration," but instead, it's become a "catastrophe in the making." That's Axios' recent take on Aduhelm , the costly new Alzheimer's drug that was approved by the Food and Drug Administration despite major reservations from...

Cost of Alzheimer's Drug Could Push Medicare to the Brink

Biogen product would nearly double program's medication budget, though it might not work

(Newser) - The Food and Drug Administration's approval of a new drug to treat Alzheimer's disease could have enormous implications not just for patients, but for Medicare—even pushing the program toward collapse. FDA approval historically has meant Medicare will cover the cost of the medication, but with Biogen's...

Alzheimer Drug 'Debacle' Continues With Yet Another Resignation

Aaron S. Kesselheim is 3rd FDA adviser to resign after agency approves Aduhelm

(Newser) - The "debacle" over an Alzheimer's drug recently approved by the Food and Drug Administration continues, or at least that's how the commotion is being described by a third adviser to the agency who's now quit over it. Mayo Clinic neurologist Dr. David Knopman and Washington University...

Reagan's Daughter Has a Fear About Alzheimer's Drug

What if Aduhelm keeps people in an awful state of limbo, asks Patti Davis

(Newser) - Ronald Reagan's daughter is raising a concern about Aduhelm , the first new drug approved to treat Alzheimer's in nearly 20 years. In an essay at USA Today , Patti Davis recalls the "heartbreaking" early stages of her father's disease. He would struggle to come up with a...

FDA Advisers Quit Over Alzheimer's Drug: 'Sham Process'

They're not happy the agency OK'd Biogen's Aduhelm against panel's recommendation

(Newser) - The week kicked off with controversy swirling around aducanumab, the drug being marketed by Biogen as Aduhelm to treat Alzheimer's disease. The drama continues, with two members of an advisory panel to the Food and Drug Administration stepping down over the agency's decision to OK the drug against...

FDA Approves Controversial New Alzheimer's Drug

Biogen's aducanumab receives green light, despite questions about effectiveness

(Newser) - Big news in the world of Alzheimer's: The FDA on Monday approved the first new treatment in nearly 20 years, disregarding warnings from independent advisers that the drug hasn't been shown to help slow the brain-destroying disease, per the AP . The drug aducanumab is made by Biogen and...

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