Leqembi (lecanemab) Approved: What Does It Mean for You?

Jul 11, 2023 | Dr. Melanie Chandler, HABIT FL Director | @drmelaniechandler | Comments (3)

After a disappointing non-starter for Aduhelm (aducanumab) a couple of years ago, the newest version of a medication targeting the disease process in Alzheimer's disease is here: Leqembi (generic name, lecanemab).

What do you need to know?

Leqembi is an infusion based medication (meaning it has to be delivered at intervals by your doctor via injections) that targets amyloid in the brain. Amyloid makes up the "plaques" in the "plaques and tangles" that are the hallmarks of Alzheimer's disease pathology in the brain.

Follow up after 18 months showed those taking lecanemab had less amyloid in their brains compared to those receiving the placebo injections. Those individuals were also shown to have slower decline in function compared to those receiving placebos. This is likely the headline grabber you've seen all over the news or internet this week. But, what does that mean?

To put it in perspective, the research trial results highlight how those on lecanemab declined 1.21 points on an 18 point measure of daily functional ability compared to 1.66 points for those on placebo. That is less than 1/2 a point on an 18 point measure. It is statistically significant.

The question remains how significant is it to daily life when you put it into perspective with the potential risks. Swelling of the brain or hemorrhage (brain bleeds) are reported in 21.3% of those on lecanemab compared to 9.3% of controls. This is reportedly better than its amyloid fighting infusion predecessors, but still significant. Still, that chance at slowing decline, and potentially being one of those who responds best, will compel many to take this chance to help themselves or their loved one.

There will likely be far more individuals who will want lecanemab than will qualify for it. The medication really works best in those in the earliest stages, namely in the Mild Cognitive Impairment (MCI) stage in which the trial was conducted. It is also for those for whom the underlying disease process is Alzheimer's disease, and not other types of MCI or dementia.

Importantly, lecanemab was approved not just by the FDA, but also for coverage by the Centers for Medicaid and Medicare. While this will make it far more accessible than its predecessors to most people, CMS also reports patients will still owe 20% in Copay AFTER their deductibles are met. This is likely to run in the thousands of dollars.

Lecanemab is an important step closer to the goal of eliminating Alzheimer's disease. Updated information is likely to come from the Alzheimer's Association International Conference being held next week in Amsterdam on another pharmaceutical company's version of this type of medication, donanemab, which has had promising results to date.

It is amazing to see how far we've come. At the same time, it is NOT the cure we all hope for. For one, it is only targeting part of the disease process, the amyloid. Tau (the "tangles" part of "plaques and tangles") is not targeted by this medication. Neither does the medication target whatever sets off the cascade of events that causes the amyloid and tau to build-up in the first place - that is still a mystery science and medicine are trying to solve.

While we wait for the cure, medications like this are a step in the right direction. Whether it is the right medication for you, or how you can be one of the few to access it, are different matters to discuss with your physician.

You can read more at:

Alzheimer's drug lecanemab granted full approval by FDA, Mayo Clinic expert weighs in - Mayo Clinic News Network

https://www.nejm.org/doi/full/10.1056/NEJMoa2212948

https://www.cms.gov/newsroom/press-releases/statement-broader-medicare-coverage-leqembi-available-following-fda-traditional-approval

https://www.alz.org/news/2023/association-statement-donanemab

What do you think about Leqembi and other treatments for Alzheimer's Disease and Related Dementias?

Interested in more newsfeed posts like this? Go to the Mild Cognitive Impairment (MCI) blog.

irinig | @irinig | Sep 29, 2023

We are all Guinea pigs at the moment so that future generations can benefit from us! This is what happens with most majors…thank you for your very insightful article. Could it work on my mother who is 94 or not?? How do I buy it for her? 🙏🙏

SusanEllen66 | @SusanEllen66 | Apr 3 12:46am

I was diagnosed with Alzheimer’s Dementia (mild) last month (February 2024).
My neurologist recommended that I apply for this new drug and now I am having second thoughts about taking it.
I am concerned about the possibility of brain bleed because I had a hemorrhagic stroke in 2007.
I guess I will see if I can even get approved. I am only 74, and live alone still with no problems.
Susan

MaryBeth | @liv4now | Apr 3 6:45am

My husband has MCI and his genetics are ApoE4/ApoE4. His Mayo neurologist said that people with that genotype showed a significantly higher risk of brain hemorrhage with Aduhelm and possibly Lequembi, since they are similar-acting drugs. Knowing your genotype is another important consideration when deciding whether or not to take Lequembi.
My husband is fortunate to be in a clinical trial for a new drug, ALZ-801, that is showing some promise for slowing the disease process. We may see results of this trial later this year. I hope and pray that we are getting closer to a cure, for our children and grandchildren.