Alzheimer’s drug Leqembi has full FDA approval now and that means Medicare will pay for it
1 year, 5 months ago

Alzheimer’s drug Leqembi has full FDA approval now and that means Medicare will pay for it

LA Times  

This image provided by Eisai in January 2023 shows vials and packaging for their medication, Leqembi. On Thursday, U.S. officials granted full approval to the closely watched Alzheimer’s drug, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease. U.S. officials granted full approval to a closely watched Alzheimer’s drug on Thursday, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease,” said FDA’s neurology drug director, Dr. Teresa Buracchio, in a statement. But Alzheimer’s patients and advocates have been lobbying the federal government for months after Medicare officials announced last year they wouldn’t pay for routine use of drugs like Leqembi until they receive FDA’s full approval.

Medicare Brain Patients Drug Approval Fda Leqembi Eisai Full Approval Full Fda Approval  means  fda  patients  drugs  treatment  brain  medicare  leqembi  alzheimers  pay  drug  approval

History of this topic

UK regulator approves second Alzheimer's drug in months but government won't pay for it
2 months ago

UK regulator approves second Alzheimer's drug in months but government won't pay for it

The Independent  

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Second Alzheimer’s drug expected to be blocked for NHS use
4 months ago

Second Alzheimer’s drug expected to be blocked for NHS use

The Telegraph  

A second Alzheimer’s drug is expected to be blocked for use by the NHS, The Telegraph can reveal. This week, the breakthrough drug lecanemab was declared safe by the medicines regulator but was not approved for use on the NHS by the health service’s spending watchdog. Insiders told The Telegraph that the National Institute for Health and Care Excellence, which …

European committee says Alzheimer’s treatment Leqembi shouldn’t get marketing approval
4 months, 4 weeks ago

European committee says Alzheimer’s treatment Leqembi shouldn’t get marketing approval

Associated Press  

Shares of Biogen slid Friday after a European regulatory committee said the Alzheimer’s treatment Leqembi should not receive marketing approval. The European Medicines Agency committee said concerns about the drug’s potential side effects outweigh the impact it has in slowing the fatal, mind-robbing disease. Japanese drugmaker Eisai developed Leqembi and is co-marketing it with Cambridge, Massachusetts-based Biogen Inc. An Eisai …

Eli Lilly Alzheimer's drug approved by US FDA
5 months, 3 weeks ago

Eli Lilly Alzheimer's drug approved by US FDA

Hindustan Times  

By Bhanvi Satija Eli Lilly Alzheimer's drug approved by US FDA July 2 - The U.S. Food and Drug Administration on Tuesday approved Eli Lilly's treatment for early Alzheimer's, making it the second therapy for slowing progression of the brain-wasting disease that will be available to U.S. patients. The approval for donanemab, to be sold under brand name Kisunla, followed …

Alzheimer’s drug that can slow disease gets backing from FDA advisers
6 months, 1 week ago

Alzheimer’s drug that can slow disease gets backing from FDA advisers

Associated Press  

WASHINGTON — A closely watched Alzheimer’s drug from Eli Lilly won the backing of federal health advisers on Monday, setting the stage for the treatment’s expected approval for people with mild dementia caused by the brain-robbing disease. Food and Drug Administration advisers voted unanimously that the drug’s ability to slow the disease outweighs its risks, including side effects like brain …

FDA advisers strongly back new Alzheimer’s drug, despite risks and limitations
6 months, 2 weeks ago

FDA advisers strongly back new Alzheimer’s drug, despite risks and limitations

NPR  

FDA advisers strongly back new Alzheimer’s drug, despite risks and limitations toggle caption Andrew Harnik/AP Advisers to the Food and Drug Administration have recommended unanimously that the agency approve the Alzheimer’s drug donanemab. At a meeting Monday, the Peripheral and Central Nervous System Drugs Advisory Committee voted 11-0 that donanemab is effective at slowing down Alzheimer’s in the disease’s early …

It’s the first drug shown to slow Alzheimer’s. Why is it off to a slow start?
8 months, 1 week ago

It’s the first drug shown to slow Alzheimer’s. Why is it off to a slow start?

Associated Press  

The first drug shown to slow Alzheimer’s disease hit the U.S. market over a year ago, but sales have lagged, major hospital systems have taken months to start using it and some insurers have rejected coverage. “As we learn more, we’ll expand and extend it.” The Mayo Clinic in Rochester, Minnesota, started using Leqembi in October but only for patients …

FDA will take a deeper look into the safety and effectiveness of Lilly experimental Alzheimer’s drug
9 months, 2 weeks ago

FDA will take a deeper look into the safety and effectiveness of Lilly experimental Alzheimer’s drug

Associated Press  

INDIANAPOLIS — Federal regulators put off a decision on whether to approve an Eli Lilly Alzheimer’s drug by making an unusual request to have outside advisers look at the treatment. Eli Lilly and Co. Executive Vice President Anne White said in a statement that the Indianapolis-based company remains confident in donanemab’s potential and will work with the FDA. Donanemab is …

Biogen will stop selling its controversial Alzheimer’s drug Aduhelm
10 months, 3 weeks ago

Biogen will stop selling its controversial Alzheimer’s drug Aduhelm

Associated Press  

Biogen will stop selling its Alzheimer’s treatment Aduhelm, a drug once seen as a potential blockbuster that stumbled after its launch a few years ago. The company also is helping Japanese drugmaker Eisai sell another Alzheimer’s treatment, Leqembi, which received full FDA approval last summer. When Aduhelm debuted in 2021, it was the first new Alzheimer’s drug in nearly two …

Insurers won’t cover new Alzheimer’s treatment for some customers
1 year, 4 months ago

Insurers won’t cover new Alzheimer’s treatment for some customers

Associated Press  

Some private insurers are balking at paying for the first drug fully approved to slow mental decline in Alzheimer’s patients. Insurers selling coverage in North Carolina, Pennsylvania and New York, among other states, told The Associated Press they won’t cover Leqembi with insurance offered on the individual market and through employers because they still see the $26,000-a-year drug as experimental. …

Second Alzheimer’s drug in pipeline can slow the disease by a few months but with safety risk
1 year, 5 months ago

Second Alzheimer’s drug in pipeline can slow the disease by a few months but with safety risk

LA Times  

New research shows an experimental Alzheimer’s drug from Eli Lilly and Co. can modestly slow patients’ inevitable worsening, though it comes with safety concerns. Another experimental Alzheimer’s drug can modestly slow patients’ inevitable worsening — by about four to seven months, researchers reported this week. “Diabetes doesn’t have a cure either — it doesn’t mean you can’t have very meaningful …

New drug for Alzheimer's gives hope and ushers in new era in fighting the disease, says doctor
1 year, 5 months ago

New drug for Alzheimer's gives hope and ushers in new era in fighting the disease, says doctor

NL Times  

Alzheimer's used to be a disease that could not be cured. On Monday, however, the results of the second new drug for Alzheimer's will be announced, and that seems to herald a new era, says neurologist Niels Prins, director of the Brain Research Center. "It will be possible to counteract the disease, and that has never been done before in …

First drug to slow Alzheimer's progression approved in US | 5 points
1 year, 5 months ago

First drug to slow Alzheimer's progression approved in US | 5 points

Hindustan Times  

US drug regulator on Thursday granted full approval to Alzheimer's drug Leqembi, manufactured by a Japanese firm Eisai. The company had earlier received conditional approval from the Food and Drug Administration in January based on early results suggesting Leqembi worked on Alzheimer's patients by clearing a sticky brain plaque linked to the disease. The drug is among the most potent …

US FDA grants standard approval of Eisai, Biogen Alzheimer's drug
1 year, 5 months ago

US FDA grants standard approval of Eisai, Biogen Alzheimer's drug

India Today  

Eisai and Biogen's Leqembi won a coveted standard approval nod from the U.S. Food and Drug Administration on Thursday, the first Alzheimer's treatment to achieve that goal, clearing the way for wider insurance coverage of the drug. The FDA placed its strongest "boxed" safety warning on Leqembi's label, flagging the risk of potentially dangerous brain swelling for Alzheimer's drugs in …

Alzheimer: This Country Has Approved New Drug That Will Combat Cognitive Decline
1 year, 5 months ago

Alzheimer: This Country Has Approved New Drug That Will Combat Cognitive Decline

News 18  

The US drug regulator gave full approval to a new Alzheimer’s medicine on Thursday, a move that makes it more widely available to the public through government-run health insurance for the elderly. “This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease,” senior FDA official Teresa Buracchio said in a statement. “This treatment, …

Alzheimer’s drug Leqembi has full FDA approval now and that means Medicare will pay for it
1 year, 5 months ago

Alzheimer’s drug Leqembi has full FDA approval now and that means Medicare will pay for it

Associated Press  

WASHINGTON — U.S. officials granted full approval to a closely watched Alzheimer’s drug on Thursday, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease. The Food and Drug Administration endorsed the IV drug, Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer’s disease. “This confirmatory …

Alzheimer's drug Leqembi gets full FDA approval. Medicare coverage will likely follow
1 year, 5 months ago

Alzheimer's drug Leqembi gets full FDA approval. Medicare coverage will likely follow

NPR  

Alzheimer's drug Leqembi gets full FDA approval. Medicare coverage will likely follow Enlarge this image toggle caption Andrew Harnik/AP Andrew Harnik/AP The Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer's disease. In January, the drug received what's known as accelerated approval from the FDA, based on its ability to remove the substance beta-amyloid …

FDA panel unanimously endorses Lecanemab for Alzheimer's treatment, offering hope to millions
1 year, 6 months ago

FDA panel unanimously endorses Lecanemab for Alzheimer's treatment, offering hope to millions

Hindustan Times  

A major breakthrough in Alzheimer's treatment has emerged as the Food and Drug Administration panel unanimously endorsed the use of lecanemab to combat the progression of the debilitating disease. Clinical trial results of lecanemab were hailed as "robust" and "clear and consistent" by experts, offering a glimmer of hope for the estimated 6.5 million individuals affected by Alzheimer's. Researchers from …

Alzheimer's drug gets FDA panel's backing, setting the stage for broader use
1 year, 6 months ago

Alzheimer's drug gets FDA panel's backing, setting the stage for broader use

The Hindu  

Health advisers on Friday unanimously backed the full approval of a closely watched Alzheimer’s drug, a key step toward opening insurance coverage to U.S. seniors with early stages of the brain-robbing disease. The FDA panel of outside advisers voted 6-0 that a large company study confirmed the drug's benefits for patients with mild or early Alzheimer's. The FDA’s initial OK …

Alzheimer’s drug gets FDA panel’s backing, setting the stage for broader use
1 year, 6 months ago

Alzheimer’s drug gets FDA panel’s backing, setting the stage for broader use

Associated Press  

WASHINGTON — Health advisers on Friday unanimously backed the full approval of a closely watched Alzheimer’s drug, a key step toward opening insurance coverage to U.S. seniors with early stages of the brain-robbing disease. The FDA panel of outside advisers voted 6-0 that a large company study confirmed the drug’s benefits for patients with mild or early Alzheimer’s. The FDA’s …

First ever drug found to slow Alzheimer’s submitted for approval
1 year, 6 months ago

First ever drug found to slow Alzheimer’s submitted for approval

The Telegraph  

The first ever drug found to slow Alzheimer’s has gone to Britain’s regulators for approval. The findings of the phase-three clinical trial were the first to ever show a drug can slow Alzheimer’s. Richard Oakley, Associate Director of Research at Alzheimer’s Society, said: “This is exciting progress and means that we could hear if lecanemab has been approved by early …

Benefits of lecanemab, a new Alzheimer's drug, unclear for patients of color : Short Wave : NPR
1 year, 9 months ago

Benefits of lecanemab, a new Alzheimer's drug, unclear for patients of color : Short Wave : NPR

NPR  

How well does a new Alzheimer's drug work for those most at risk? A new drug for Alzheimer's disease, called lecanemab, got a lot of attention earlier this year for getting fast-tracked approval based on a clinical trial that included nearly 1,800 people. The clinical trial for lecanemab was the most diverse for an Alzheimer's treatment to date, but it …

Why a new Alzheimer’s drug is having a slow US debut
1 year, 10 months ago

Why a new Alzheimer’s drug is having a slow US debut

Associated Press  

The first drug to show that it slows Alzheimer’s is on sale, but treatment for most patients is still several months away. Eisai spokeswoman Libby Holman said prescriptions for the drug have been written, and they expect patients to start receiving it “very soon.” COST AND COVERAGE A year’s treatment will run about $26,500. The Centers for Medicare and Medicaid …

EXPLAINER: New drug slows Alzheimer’s but comes with caveats
1 year, 11 months ago

EXPLAINER: New drug slows Alzheimer’s but comes with caveats

Associated Press  

WASHINGTON — A new Alzheimer’s drug is hitting the market — the first with clear-cut evidence that it can slow, by several months, the mind-robbing disease. In Eisai’s 18-month study of nearly 1,800 people, Leqembi appeared to delay early-stage patients from getting worse by about five months. People who got the drug still worsened but not as rapidly as those …

US: FDA approves anti-Alzheimer's drug
1 year, 11 months ago

US: FDA approves anti-Alzheimer's drug

Hindustan Times  

The US Food and Drug Administration on Friday approved a new drug designed to slow cognitive decline in those suffering from Alzheimer's disease. It follows the approval of the anti-Alzheimer's drug Aduhelm, which a US congressional investigation criticized for alleged "irregularities." The FDA said in a statement that Leqembi and Aduhelm represent "an important advancement in the ongoing fight to …

US approves Alzheimer’s drug that modestly slows disease
1 year, 11 months ago

US approves Alzheimer’s drug that modestly slows disease

Associated Press  

WASHINGTON — U.S. health officials on Friday approved a closely watched Alzheimer’s drug that’s been shown to modestly slow the early stages of the brain-robbing disease, albeit with potential safety risks that doctors and patients will have to carefully weigh. Last week, a congressional report found that FDA’s approval of a similar Alzheimer’s drug called Aduhelm — also from Biogen …

U.S. approves Alzheimer’s drug that modestly slows disease
1 year, 11 months ago

U.S. approves Alzheimer’s drug that modestly slows disease

LA Times  

This Dec. 21, 2022 image provided by Eisai in January 2023, shows vials and packaging for their medication Leqembi. U.S. health officials on Friday approved a closely watched Alzheimer’s drug that modestly slows the brain-robbing disease, albeit with potential safety risks that patients and their doctors will have to carefully weigh. Last week, a congressional report found that FDA’s approval …

Probe: Alzheimer’s drug approval ‘rife with irregularities’
1 year, 11 months ago

Probe: Alzheimer’s drug approval ‘rife with irregularities’

Associated Press  

WASHINGTON — The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators and a company it’s supposed to oversee -- Aduhelm manufacturer Biogen. Thursday’s report urged the agency to “take swift action” …

Alzheimer’s drug approval by FDA ‘rife with irregularities,’ probe finds
1 year, 11 months ago

Alzheimer’s drug approval by FDA ‘rife with irregularities,’ probe finds

LA Times  

The FDA’s contentious approval of the questionable Alzheimer’s drug Aduhelm took another hit, as congressional investigators called the process “rife with irregularities.” The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators …

Explained | Will new drug slow progress of Alzheimer’s?
2 years ago

Explained | Will new drug slow progress of Alzheimer’s?

The Hindu  

The story so far: In late November, news of the success of a drug to reduce cognitive decline in patients with Alzheimer’s disease burst on the horizon with all the promise of being a silver bullet. This class of drugs does precisely that.” As per the NEJM paper, the clinical trial, conducted over 18-months, a multi-centre, double-blind, phase 3 trial, …

Is the new drug lecanemab a breakthrough for Alzheimer’s?
2 years ago

Is the new drug lecanemab a breakthrough for Alzheimer’s?

Hindustan Times  

There’s news in the world of Alzheimer’s research. In a phase three trial, drug companies Biogen and Eisai reported this week that lecanemab, an experimental monoclonal antibody, reduced cognitive decline caused by the disease by 27% after 18 months. This trial proves that Alzheimer’s disease can be treated," Bart De Strooper, Director of the UK Dementia Research Institute, told reporters. …

New drug appears to slow Alzheimer’s, but can it make a real difference?
2 years ago

New drug appears to slow Alzheimer’s, but can it make a real difference?

LA Times  

An experimental Alzheimer’s drug modestly slowed the brain disease’s inevitable worsening, researchers reported Tuesday — but it remains unclear how much difference that might make in people’s lives. Japanese drugmaker Eisai and its U.S. partner, Biogen, had announced earlier this fall that the drug, lecanemab, appeared to work, a badly needed bright spot after repeated disappointments in the quest for …

Drug that reverses dementia will be wasted without better diagnosis rates, experts warn
2 years ago

Drug that reverses dementia will be wasted without better diagnosis rates, experts warn

The Telegraph  

The latest published data shows that as of 2019, Britain had just 70 PET-CT scanning locations, less than half the number of those available in comparable EU countries. “We need everyone to be told which disease is causing their dementia symptoms, and if they have Alzheimer’s disease, a follow-up scan or CSF test to check if they are amyloid positive …

Alzheimer’s drug shows promise in early results of study
2 years, 2 months ago

Alzheimer’s drug shows promise in early results of study

Associated Press  

Shares of Biogen and other drugmakers researching Alzheimer’s disease soared Wednesday after Japan’s Eisai Co. said its potential treatment appeared to slow the fatal disease in a late-stage study. The drugmaker said early results showed that its treatment, lecanemab, reduced patient clinical decline by 27% when compared to a placebo or fake drug after 18 months of the infused treatment. …

Alzheimer’s drug cited as Medicare premium jumps by $21.60
3 years, 1 month ago

Alzheimer’s drug cited as Medicare premium jumps by $21.60

Associated Press  

WASHINGTON — Medicare’s “Part B” outpatient premium will jump by $21.60 a month in 2022, one of the largest increases ever. Medicare officials told reporters on Friday that about half the increase is due to contingency planning if the program ultimately has to cover Aduhelm, the new $56,000-a-year medication for Alzheimer’s disease from pharmaceutical company Biogen. “The increase in the …

FDA trims use of contentious Alzheimer’s drug amid backlash
3 years, 5 months ago

FDA trims use of contentious Alzheimer’s drug amid backlash

Associated Press  

WASHINGTON — A month after approving a controversial new Alzheimer’s drug, U.S. health regulators on Thursday signed off on new prescribing instructions that are likely to limit its use. When the drug was first approved, a top FDA official told reporters the drug was “relevant to all stages of Alzheimer’s disease.” The FDA’s OK last month quickly sparked controversy over …

Alzheimer’s disease drug: FDA narrows prescribing information
3 years, 5 months ago

Alzheimer’s disease drug: FDA narrows prescribing information

CNN  

CNN — The US Food and Drug Administration has narrowed the group of Alzheimer’s disease patients who should receive the controversial drug aducanumab, sold as Aduhelm. The FDA approved changing the drug’s label to clarify that the treatment is intended specifically for patients with mild cognitive impairment or milder stages of disease, according to an announcement Thursday from the companies …

Opinion: New Alzheimer’s drug sets dangerous precedent
3 years, 6 months ago

Opinion: New Alzheimer’s drug sets dangerous precedent

CNN  

Editor’s Note: Reshma Ramachandran, MD, MPP is a physician-fellow at the National Clinician Scholars Program at the Yale School of Medicine whose research and policy work centers on the realignment of incentives to ensure patients access to affordable, effective, and safe treatment. CNN — Last week, the US Food and Drug Administration approved aducanumab as a treatment for Alzheimer’s disease …

Column: The FDA’s hasty approval of a new Alzheimer’s drug is looking worse than ever
3 years, 6 months ago

Column: The FDA’s hasty approval of a new Alzheimer’s drug is looking worse than ever

LA Times  

Following a year in which the Food and Drug Administration meekly allowed President Trump to denigrate its integrity and undermine its judgment, it wasn’t clear that the agency could fall even lower in public and professional esteem. The FDA’s widely criticized decision on June 7 to approve the new Alzheimer’s drug Aduhelm despite a nearly complete absence of evidence that …

Why The FDA's Approval Of A New Alzheimer's Drug Should Worry You
3 years, 6 months ago

Why The FDA's Approval Of A New Alzheimer's Drug Should Worry You

Huff Post  

LOADING ERROR LOADING You might expect Mariah Robertson to applaud last week’s approval of a new drug for Alzheimer’s disease. In the meantime, the Aduhelm decision could set a precedent for how the FDA approaches other treatments ― an “enormously risky move,” as STAT writer Matthew Herper put it, “that could accelerate the public’s access to medicines but upend the …

Medicare copays for new Alzheimer’s drug could reach $11,500
3 years, 6 months ago

Medicare copays for new Alzheimer’s drug could reach $11,500

Associated Press  

WASHINGTON — A new $56,000-a-year Alzheimer’s drug would raise Medicare premiums broadly, and some patients who are prescribed the medication could face copayments of about $11,500 annually, according to a research report published Thursday. “At this price, the cost of this one drug alone could top all others covered by Medicare, if it is used widely,” said Tricia Neuman, coauthor …

Medicare Copays For New Alzheimer's Drug Could Reach $11,500 Annually
3 years, 6 months ago

Medicare Copays For New Alzheimer's Drug Could Reach $11,500 Annually

NPR  

Medicare Copays For New Alzheimer's Drug Could Reach $11,500 Annually Enlarge this image toggle caption Biogen via AP Biogen via AP WASHINGTON — A new $56,000-a-year Alzheimer's drug would raise Medicare premiums broadly, and some patients who are prescribed the medication could face copayments of about $11,500 annually, according to a research report published Thursday. "At this price, the cost …

EXPLAINER: How will insurers cover a new Alzheimer’s drug?
3 years, 6 months ago

EXPLAINER: How will insurers cover a new Alzheimer’s drug?

Associated Press  

Federal regulators have approved the first new drug for Alzheimer’s disease in nearly 20 years, leaving patients waiting to see how insurers will handle the pricey new treatment. The Food and Drug Administration said it granted approval to a drug from Biogen based on clinical research results that seemed “reasonably likely” to benefit Alzheimer’s patients. Patients with Medicare Advantage coverage, …

FDA approves much-debated Alzheimer’s drug panned by experts
3 years, 6 months ago

FDA approves much-debated Alzheimer’s drug panned by experts

Associated Press  

WASHINGTON — Government health officials on Monday approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease. The Food and Drug Administration approved the drug from Biogen based on study results showing it seemed “reasonably likely” to benefit Alzheimer’s patients. …

Alzheimer’s disease drug could get closer to FDA approval
4 years, 1 month ago

Alzheimer’s disease drug could get closer to FDA approval

CNN  

CNN — The US Food and Drug Administration soon will consider whether to approve a new Alzheimer’s drug for the first time in almost two decades. The agency’s Peripheral and Central Nervous System Drugs Advisory Committee will meet on Friday to discuss aducanumab, an experimental treatment administered through intravenous infusion for early Alzheimer’s disease. “There has not been an approval …

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