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FDA Approves New Alzheimer’s Drug, Leqembi

Lecanemab packaging with its brand name, Leqembi.

January 9th, 2023 — The US Food and Drug Administration (FDA) has recently approved amyloid-targeting drug Leqembi (lecanemab) for the treatment of early stage Alzheimer’s disease. This is a historic development for those affected by this debilitating disease and their loved ones.

Lecanemab demonstrated promising results in clinical trials, with patients experiencing a 27 percent slower decline in cognitive function in tandem with reducing the amount of amyloid protein found in the brain in Alzheimer’s disease. However, as with any new drug, there are also potential risks and side effects to consider with Leqembi (pronounced le-KEM-bee). 

The drug was provided via intravenous infusion every two weeks for 18 months in its hallmark clinical trial. The drug met its primary study outcome of slowing cognitive decline as well as many of its other measures of cognitive function and quality of life. Lingering questions remain about how noticeable and clinically meaningful this effect will be on patients. There are some questions about the long term safety of the drug, especially after there were three cases reported of patients who died while on the drug – whether death was due directly as a consequence of the drug is still under investigation.

Those who are more cautious might pay closer attention to the study’s conclusion published in the New England Journal of Medicine that “longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.” However, the potential risks may not outweigh the potential benefits for some, especially when the magnitude of benefit can depend so much on individual circumstances. This is why it is so important for patients to thoughtfully weigh the potential benefits and risks of treatment with their healthcare provider.

If Leqembi is deemed to be a suitable option for you and choose to move forward with this drug, there will still be some limitations to access. The first is financial. The list price of Leqembi is $26,500 per year. Whether, how much, and when this drug price would be covered by insurances is yet to be determined. There was a national coverage determination by the Center for Medicare and Medicaid Services (CMS) stating that an Alzheimer’s drug directed against amyloid would be covered if it received traditional approval from the FDA under coverage with evidence development (CED) – meaning that there would be better access and coverage for people with Medicare that participate in a CMS-approved study. If the FDA determines additional evidence suggests that the drug more clearly helps patients, Medicare may cover it more fully for eligible patients so long as their experience while taking the medication is tracked long term.

The FDA has provided clearer cautions on the label that more detail and clarity is still needed to truly understand who are the best patients for the drug and about its safety, especially when severe risks can include brain swelling, brain bleeding, and a potentially greater propensity for bleeding in people using blood thinning medications.

Although questions remain about this drug, there are ongoing studies to help provide the clarity needed for the FDA to decide whether to grant full approval for Leqembi and whether Medicare would cover it.

If you or a loved one has been diagnosed with early onset Alzheimer’s disease and are interested in exploring treatment options like Leqembi, we encourage you to contact a memory specialist at Isaac Health. Our team can help you understand the eligibility requirements for the clinical study and assist with the enrollment process if you qualify. It is important to note that not all patients with early onset Alzheimer’s disease may be eligible as specific criteria must be met. However, our team at Isaac Health can provide more information and help you determine if you or your loved one may be a candidate for treatment with Leqembi. Don’t let Alzheimer’s disease control your future, take control and contact Isaac Health today to learn more about your treatment options. If interested, please feel free to join our waiting list here.

About Isaac Health

Isaac Health is a specialized online memory health service that arranges for patients to meet with a telehealth clinician who can diagnose and treat memory loss, Alzheimer’s dementia, and other related conditions. Isaac Health provides medical care and cognitive therapy for patients who are concerned about symptoms of dementia.
For more information or If you’d like to understand whether you or a loved one may benefit from new Alzheimer’s disease treatments, schedule a free no-obligation discovery consultation with a member of the Isaac Health team.

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