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    1 year ago

    Advisory Committee (Adcomm) Results: Donanemab

    ADVISORY COMMITTEE (ADCOMM) RESULTS: DONANEMAB

    Posted June 11, 2024

    On June 10, 2024, an 11-member panel of independent scientific and clinical advisors, convened by the Food and Drug Administration (FDA), voted unanimously to recommend Eli Lilly’s drug donanemab for approval in the treatment of Alzheimer’s disease, citing that the potential benefits outweigh the risks. The FDA will consider the panel’s recommendation before making a final determination to approve or reject the drug. If approved, donanemab would become the second drug currently available on the market to treat Alzheimer’s disease. Leqembi, a drug in the same class, was approved in 2023.

    ”We are excited to see a second drug reach this milestone in the FDA regular approval process. We thank the FDA and the members of the Advisory Committee for their thoughtful, patient-centric discussion of donanemab and its risk/reward profile for individuals in the earliest stages of clinical Alzheimer’s disease, and look forward to the FDA’s final decision later this year.” 

    Background

    Donanemab is a monoclonal antibody that targets a form of amyloid beta that builds up in the bundles of plaque that accumulate in the brain. Anti-amyloid monoclonal antibody drugs, including donanemab, are immunotherapies designed to increase the normal clearance of this pathology by the brain’s innate immune cells.

    • The phase 3 donanemab study included 1,700 patients between the ages of 60-85 years of age who had both amyloid and tau pathology in their brains as confirmed by imaging tests. Other phase 3 trials of drugs in this class have only screened participants for amyloid pathology.
    • All participants were also clinically diagnosed with mild cognitive impairment or mild dementia due to Alzheimer’s disease.
    • A control group of participants received a placebo so that the treated group could be compared to untreated participants on metrics of safety, brain pathology levels, and cognitive function.
    • The treatment was administered intravenously once a month for up to 18 months. Imaging was used to monitor the effects of the treatment.
    • Participants stopped treatment but continued to be assessed in the trial when their brain amyloid dropped below the diagnostic threshold. This is a key difference between the donanemab trial and past phase 3 trials of other drugs in this class.
    • To date, all drugs in this class are associated with the same potential side effect, ARIA (amyloid-related imaging abnormalities), but the rates were higher in the donanemab trial than in the phase 3 trials of aducanumab (Aduhelm) and lecanemab (Leqembi). Most cases of ARIA are asymptomatic or mild. Symptoms include headache, confusion, dizziness, nausea, and, in a few rare cases, seizures. Approximately 24% of trial participants treated with donanemab experienced brain swelling and 31% experienced bleeding in the brain.
    • Nineteen participants died during the trial and three of the deaths were attributed to donanemab. This compares to sixteen patients who died during the trial and who were treated with a placebo.

    At the end of the 18-month trial, the treatment group had declined 29% less on an assessment of cognitive function than the untreated participants, even though many in the treatment group were able to stop treatment in a year or less due to reduction of beta-amyloid. This result is similar to that seen in the phase 3 trial that led to FDA approval for another anti-amyloid monoclonal antibody, Leqembi.

    AdComm Background and Results

    The AdComm voted unanimously that donanemab should be approved and that its clinical benefits outweigh the risks of brain swelling and hemorrhage associated with this class of drugs.

    In news coverage from STAT, one member of the AdComm, Stanford neurologist Kathleen Poston, summarized the group’s thinking: “The benefits outweigh the risks, as long as the risks are being monitored.”

    • The FDA convenes panels of outside experts, often clinicians, to provide input to its drug approval decision-making. These experts review extensive data and analysis prepared by the drug sponsor and FDA staff. The FDA does not have to convene these meetings to approve a drug and does not have to follow their recommendations, but it often does ask AdComms to vote on specific questions about a drug and whether it should be approved.
    • Members of the public are also offered an opportunity to provide input and the AdComm discussion touched on how differently individual patients may judge the risks and rewards of treatment for Alzheimer’s.
    • The donanemab AdComm was closely watched for two reasons. First, the FDA disregarded negative guidance from an AdComm and moved forward to approve aducanumab (marketed as Aduhelm), the first anti-amyloid immunotherapy alleged to show cognitive benefit to a treatment subgroup in a phase 3 clinical trial. Many AdComm members resigned and Aduhelm was eventually removed from the market after poor sales and severe restrictions on coverage from the Centers for Medicare and Medicaid. Second, Leqembi is another drug in this class with similar efficacy and safety data, so the FDA’s decision to call an AdComm on donanemab late in the approval process was a surprise.
    • In discussions, the AdComm and FDA also indicated that the drug’s label, which indicates the guidelines for prescriptions, should not require confirmation that patients have tau pathology. Tau imaging is not widely available clinically, and requiring it would significantly reduce access to donanemab.
    • AdComm members also highlighted that the donanemab trial, similar to the Leqembi and Aduhelm trials, had insufficient numbers of Black and Hispanic participants to provide adequate safety and efficacy data for these populations.

    1 year ago

    My Dance With Alzheimer’s: Striving Through Imperfection

    Posted May 30, 2024


    By Greg O'Brien


    “The greatest obstacle to discovery is not ignorance, it is the illusion of knowledge.” (the late Daniel J. Boorstin, distinguished historian)

    At 74, fighting advancing Alzheimer’s, I’ve found peace in imperfection—the illusion of knowledge. My mind used to be my best friend; now there’s no chance for reconciliation. So I write and think from the heart, the place of the soul.

    My heart now tells me that I’m not perfect—though, arrogantly at times, I thought I might be. But I never was perfect, no matter what my Irish mother often insisted. Yet, she had Alzheimer’s as well.

    Alzheimer’s has brought me to the realization of imperfection—and it’s a gift.

    I’ve learned the hard way that it’s okay not to be perfect, to have imperfect parents and children, or to not strive in risky ways for perfection. There’s no guilt here; in fact, there’s inner strength. Reality is a pill we all should swallow. Society and the advertising media continually pressure us to be faultless individuals, raising in us Superman expectations that are hazardous to our spirit and about as real as Kryptonite. Failure, as measured against success, is not an option that we generally like to declare, but acknowledgment of failure can be freeing to the soul.

    Einstein had something to say about this: “There is nothing known as ‘Perfect.’ It’s only those imperfections which we choose not to see!!”

    And Winston Church, who scholars say suffered from depression and perhaps Bipolar disorder, once observed: “Perfection is the enemy of progress.”

    Alzheimer’s has enhanced my perspective. And that’s progress. I’ve found peace in my shortcomings—a perseverance to press on in the face of difficulties, which now include prostate cancer, a breakdown of my body, and deep depression. Now, as part of my limitations, I get angry with God when synapses in my brain are not working. I often explode loudly (generally privately), taking the Lord’s name in vain. I feel deep guilt about this as if I’ve just burned down a convent full of nuns.

    Yet, God, or the universe if you will, has big shoulders and forgives. I see God, in my imperfections, as a cross between “Lurch” in the old Addams Family sitcom with his deep resonant groans and Kojak’s Telly Savalas: “Who loves ya, Baby!”

    And so I’ve had to forgive myself.

    Cautions Harvard University’s Division of Continuing Education about trying to be perfect: “For many, working hard and doing their best is achievement enough, even if they don’t get a perfect score. However, for those wrestling with perfectionism, doing their best isn’t enough, and they’ll strive to be perfect at the expense of their own health and wellness…being human inherently means being imperfect. While it’s good to strive for your best in many situations, perfectionism says that everything you do has to be perfect — and anything less than that is unacceptable.

    “Individuals with perfectionist tendencies may have historically been rewarded for good work, and are conditioned to seek that out again. They may believe they must be perfect to please their parents or earn their family’s respect. They may have a fear of failure and believe that they can avoid it by being perfect. Or they may need to meet unrealistic expectations in a world of curated, seemingly ’perfect’ lives on social media. But whatever the cause, perfectionism isn’t a healthy way to approach the world.”

    In this imperfect world, people and their families battling Alzheimer’s need tools to fight Alzheimer’s. These tools and resources are available through:

    • Cure Alzheimer’s Fund (https://curealz.org/), which targets breakthrough research
    • Harvard Health Publishing (https://www.health.harvard.edu/mind-and-mood/shield-your-brain-from-decline)
    • Dr. Rudy Tanzi, a world-renowned Alzheimer’s expert, Harvard professor of neurology, co-director of the Henry and Allison McCance Center for Brain Health at Massachusetts General Hospital, and Chair of the Cure Alzheimer’s Fund Research Leadership Group (https://curealz.org/researchers/rudy-tanzi/).

    My late father, who also died of dementia, once told me, quoting from someone else: “Life is like a river; you need to study it, as it goes by, then decide the right time to put your feet in the water.”

    Upon my diagnosis of Alzheimer’s, my doctor and close friend, instructed me: “You need to learn to dance with Alzheimer’s.” While I’ve always been a horrible dancer, as my friends would attest—clumsy, and no rhythm— I’ve learned over time to keep a beat with Alzheimer’s, one foot at a time.

    And so it is in life, one step at a time.

    So let’s dance…


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