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BONITA SPRING, FL, July 2, 2024 — Memory Treatment Centers are thrilled to announce that the Food and Drug Administration (FDA) has approved Donanemab, a groundbreaking new drug for the treatment of Alzheimer’s disease. This approval marks a significant milestone in the ongoing battle against Alzheimer’s, a progressive brain disorder that leads to memory loss, communication difficulties, and behavioral changes.
“The full traditional FDA approval of Donanemab not only marks the advent of a new class of disease modifying therapy but signifies the neurodegenerative community’s dedication to changing the way we view and treat Alzheimer’s disease” encouraged Dr. Samuel Giles of Memory Treatment Centers Jacksonville. “We feel we have momentum towards offering true hope to our Alzheimer’s patients and caregivers and note the ongoing cohesive collaborations between clinicians, researchers, biotech and pharmaceutical organizations is at an all-time high.”
With FDA approval, Donanemab targets the beta-amyloid 42 protein plaque, which plays a crucial role in the pathology of Alzheimer’s disease by forming plaques that contribute to memory loss and brain cell death. Studies* conducted by the drug manufacturer revealed significant benefits:
• Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants’ risk of progressing to the next clinical stage of disease by up to 39%.
• Kisunla is the first and only amyloid plaque-targeting therapy that used a limited-duration treatment regimen based on amyloid plaque removal; nearly half of study participants completed their course of treatment with Kisunla in 12 months.
• Once-monthly infusions of 30 minutes reduced amyloid plaques on average by 84% compared to the start of the study.
Dr. Jamie Plante of Memory Treatment Centers Bonita Springs added, “We have just begun to explore the real-world longitudinal benefits with these therapies and identify who best will be served by each. Through continued clinical and academic evaluation, we are excited to learn more about managing the disease process from a preventative standpoint.”
“The ability to now have therapeutic options to choose from allows for improved patient/provider shared decision making. We’ve seen our patients and caregivers want to be informed about their disease and available therapeutics, and we now will be able to provide more guidance” stated Dr. Donald McCarren of Memory Treatment Centers Bonita Springs.
At Memory Treatment Centers, we are committed to supporting innovative treatments and therapies to enhance quality of life. Donanemab will be available by prescription, and we look forward to collaborating with our patients to determine if it is an appropriate treatment option for them.
Dr. Robert Mannel of Memory Treatment Centers Jacksonville added “We are moving towards being able to determine which therapeutics are most likely to be the most efficacious based on genetic factors, symptomatic disease stage and age. We are thrilled about the most recent approval with Donanemab and look forward to additional therapeutics coming down the pipeline in the near future”.
A: On July 2nd, 2024 the FDA granted full traditional approval for Donanemab (Kisunla) which is the second fully FDA approved therapy for Alzheimer’s disease that specifically targets the protein plaque beta-amyloid 42. This protein is involved in the pathology of Alzheimer’s disease by forming plaques which lead to memory loss and brain cell death. The approval of Donanemab has now allowed healthcare providers like neurologists and neurocognitive specialists, to continue to be proactive with treating and slowing the progression of Alzheimer’s disease.
A: Donanemab specifically targets the whole beta-amyloid42 protein plaques which accumulate in the brain matrix. Studies have shown that these protein plaques are one of the hallmark processes that occur early-on in Alzheimer’s disease process and their presence plays a pivotal role in Alzheimer’s dementia. By removing these plaques, clinical trials have shown that Donanemab slows progression of the disease by an average of 35% in individuals in the earliest symptomatic state of the disease (those with the lowest Tau levels). It was noted in the trials that some patients had even greater benefit.
A: Currently, there is no clinical data from the FDA trials to suggest Donanemab restores prior memory or cognitive function. Rather, the available clinical data provides support that Donanemab slows progression of Alzheimer’s disease and preserves and extends independence both cognitively and physically.
A: Donanemab is approved for the treatment of confirmed symptomatic Alzheimer’s disease for individuals with either mild dementia, or those with mild cognitive impairment (MCI); a precursor state to Alzheimer’s dementia. Patients with moderate or severe Alzheimer’s dementia are unfortunately not eligible for this therapy. This criterion is in accordance with the population studied in the clinical trials.
A: Your Neurocognitive specialist will perform a thorough assessment to determine whether a given individual is a candidate for Donanemab and/or other therapy.
A: Along with in-office assessments and neuropsychological evaluations, amyloid PET (Positron Emission Tomography) brain scans or CSF analysis (less common) are used to confirm the presence of the abnormal protein beta-amyloid-42 in the brain. Blood-based biomarkers may also be included in your assessment.
A: Either an Amyloid PET (Positron Emission Tomography) scan or a lumbar puncture (also known as a spinal tap) to obtain cerebrospinal fluid (CSF) are currently the accepted methods to confirm the presence of the abnormal protein beta-amyloid 42 plaque. However, blood-based biomarkers are rapidly growing in use and may be discussed during your visit. Your neurocognitive specialist will help guide you in determining which of these is the best study for you.
A: Donanemab is administered via an IV (intravenous) infusion that is performed once every 4 weeks. The infusion will last 30 minutes and is very well tolerated. We are still learning about how long (how many months) patients will require treatment and how frequent treatment regimens will need to be restarted. We will provide updates as more information becomes available.
A: The most common side effects associated with Donanemab treatment are amyloid related imaging abnormalities (ARIA) followed by headache, dizziness, confusion and falls. ARIA is a result of the removal of the amyloid protein plaques (the desired effect of Donanemab treatment) and usually does not result in any symptoms. The ARIA may result in either a temporary small area of swelling or very small bleeds (microbleeds) which most often resolve on their own and without any need for intervention. You will be monitored for ARIA side effects throughout treatment, including with brain imaging which is covered by insurance.
A: While amyloid related imaging abnormalities (ARIA) are seen in approximately 36.8% of those receiving the Donanemab infusions, clinical symptoms only appeared in approximately 6.1% from their ARIA. Serious symptomatic ARIA occurred in 1.6%.
A: CMS (who oversees Medicare and Medicaid) have made the determination that they are covering Donanemab treatment. Commercial insurance is expected to cover this as well. In circumstances where a given insurance company is not covering the medication, a patient assistance program may provide access. Memory Treatment Centers have been successful in providing access to Donanemab and will walk you, or your loved-one, through the process if required.
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Currently, there is one additional fully FDA approved anti-amyloid therapy available called Lecanemab (Leqembi) and more information can be found on this drug at the following link:
https://memorytreatmentcenters.com/leqembi/
A third anti-amyloid therapy named Aducanumab only received accelerated approval (not full approval) by the FDA and its production has since been discontinued.