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New Alzheimer's Disease Drug Receives Full FDA Approval

by catalinagarcia


On January 6, 2023, lecanemab (trade name Leqembi), an Alzheimer's disease drug developed by Eisai and Biogen, received conditional approval from the FDA. The results of its Phase 3 clinical trial showed that the drug slowed cognitive decline in Alzheimer's disease patients by 27%. The FDA has conducted a further review of the clinical trial results to determine whether the drug can be fully approved.

On July 6, 2023, the FDA announced that lecanemab had received traditional approval. This is reportedly the first Alzheimer's disease drug to target beta-amyloid and to transition from accelerated approval to traditional approval, as well as the first new Alzheimer's disease drug to receive full FDA approval in 20 years.

The FDA's decision is of special significance because health insurers have been delaying reimbursement payments for lecanemab until it receives full FDA approval for its treatment, which costs $26,500 per year.

Lecanemab was published in the New England Journal of Medicine (NEJM) on November 29, 2022. Results from a Phase III clinical trial involving nearly 1,800 patients with early-stage Alzheimer's disease showed that the drug slowed cognitive decline in Alzheimer's disease patients by 27%.

Lecanemab is a humanized IgG1 monoclonal antibody that works by binding to beta-amyloid ().

In the clinical trial, patients with early Alzheimer's disease received intravenous lecanemab or a placebo every two weeks for 18 months. Researchers used an 18-point scale to measure their cognitive performance. The results showed that lecanemab delayed the patients' deterioration by about five months. Additionally, patients who received lecanemab were 31% less likely to progress to the next stage of the disease during the study period.

However, adverse reactions in the clinical trial results sparked controversy. 7.3% of patients treated with the drug experienced brain hemorrhage (compared to 9% in the placebo control group), and 12.6% experienced brain swelling (compared to 1.7% in the placebo control group).

Alzheimer's disease experts remain divided on the impact of these changes in the drug on patients and families. Dr. Ron Petersen, a specialist at Mayo Medical Center, believes that the drug's effect is modest but clinically meaningful. Even if it only delays disease progression for a few months, it could provide Alzheimer's patients with more time to live and work independently.

Maria Carrillo, chief scientist at the Alzheimer's Association, stated that this clinical trial is important because it demonstrates that targeting amyloid with drugs can slow the progression of Alzheimer's disease. Delaying cognitive decline in the early stages of Alzheimer's disease has significant implications, allowing patients to spend more time with loved ones, enjoy family life, travel, take vacations, and fulfill their bucket lists.

Eisai stated that drugs targeting Aβ can cause side effects, including brain swelling and brain bleeding, and lecanemab is no exception. However, most patients experience mild or no symptoms.

According to published reports, three Alzheimer's disease patients died during clinical studies of the drug, two of them from strokes caused by brain hemorrhages. Eisai mentioned that the two deaths were due to other health problems while the patients were taking blood-thinning drugs, so these deaths cannot be attributed to the Alzheimer's disease drug.

Professor Robert Alexander from the University of Arizona, chairman of the FDA Peripheral and Central Nervous System Drugs Advisory Committee, commented that based on the results of clinical trials, lecanemab has side effects, but the monitorable nature of these side effects and the benefits to patients are evident.


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Sun Sep 29, 2024 12:23 am
candyhearts wrote a review...



Hai :3

This article is packed with interesting developments on Lecanemab!! It’s super fascinating how it's making waves, especially in Alzheimer’s research, which has been a bit stagnant in terms of major breakthroughs. I mean, full FDA approval after 20 years? That’s a huge deal!! The fact that it’s targeting beta-amyloid and actually slowing cognitive decline by 27% is impressive, especially considering how difficult it’s been to tackle Alzheimer’s head-on. That's monumental!!

I love how this article breaks down the data from the clinical trial ~~ Like, nearly 1,800 patients over 18 months is not a small amount!! That’s a massive study, and the fact that Lecanemab delayed deterioration by about five months is definitely a hopeful result for patients and families. I can totally see how even a few months could mean everything when it comes to enjoying life and spending more time with loved ones. I'm glad to see it!! That tugs at the heartstrings for sure!!

^^^ Though, isn't that something you could dive into more? I understand the point of an essay is to show the data first, but it never hurt to add some of your own emotions in. The adverse reactions are a bit scary, right? I mean, brain hemorrhage and swelling are pretty intense, even if most patients didn’t have severe symptoms. How does that make you feel? It raises questions about the long-term safety of the drug, especially for those on blood-thinning meds. Food for thought!!

Dr. Ron Petersen, a specialist at Mayo Medical Center, believes that the drug's effect is modest but clinically meaningful.


The quotes are a good touch!! I think this would be even better if there were more diverse viewpoints though ~~ Like, maybe include a critical expert’s opinion? Alzheimer’s experts are divided, but we only hear from those who lean towards an optimistic point of view here. That's not very realistic!! I think essays should be unbiased, but it seems like you're picking sides. It's best to stand in the middle of the road for writing like this. A dissenting voice could balance this out better!!

This is such an exciting yet complicated step forward in Alzheimer's treatment though!! It's cool to see an article about it!! There's hope, but there's also a lot to think about when it comes to risks and costs. That's hard to swallow, but it's the truth of the situation. What do you think? Would you take the risk for a few extra months with loved ones if you were in their shoes? I wish you answered those questions, but this is a solid essay right here!! Good job tackling all of this!!

- Payton




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Tue Sep 24, 2024 8:52 am
kaitlyn wrote a review...



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Good Morning/Afternoon/Evening/Night(whichever one it is in your part of the world),

Hi! I'm Kate and I'm here to leave a quick review!!


First Impression

This was quite a nice little article. I think it covers most of the important facts one would expect from something of this nature and does well to talk about both benefits and downsides.

Anyway let's get right to: Kate's Line by Line Reactions;

On January 6, 2023, lecanemab (trade name Leqembi), an Alzheimer's disease drug developed by Eisai and Biogen, received conditional approval from the FDA. The results of its Phase 3 clinical trial showed that the drug slowed cognitive decline in Alzheimer's disease patients by 27%. The FDA has conducted a further review of the clinical trial results to determine whether the drug can be fully approved.

On July 6, 2023, the FDA announced that lecanemab had received traditional approval. This is reportedly the first Alzheimer's disease drug to target beta-amyloid and to transition from accelerated approval to traditional approval, as well as the first new Alzheimer's disease drug to receive full FDA approval in 20 years.


Ooh this is a good opening there. Really cuts to the heart of the matter about what you're talking to and that second paragraph immediately tells us why this particular drug is one we should be taking a look at. That's a lovely opening I think, really captures our attention well.

The FDA's decision is of special significance because health insurers have been delaying reimbursement payments for lecanemab until it receives full FDA approval for its treatment, which costs $26,500 per year.

Lecanemab was published in the New England Journal of Medicine (NEJM) on November 29, 2022. Results from a Phase III clinical trial involving nearly 1,800 patients with early-stage Alzheimer's disease showed that the drug slowed cognitive decline in Alzheimer's disease patients by 27%.


Oooh good to see, moving towards some facts on the effectiveness. That builds onto the argument well once again going to show why this is important and we should care about it.

Lecanemab is a humanized IgG1 monoclonal antibody that works by binding to beta-amyloid (Aβ).

In the clinical trial, patients with early Alzheimer's disease received intravenous lecanemab or a placebo every two weeks for 18 months. Researchers used an 18-point scale to measure their cognitive performance. The results showed that lecanemab delayed the patients' deterioration by about five months. Additionally, patients who received lecanemab were 31% less likely to progress to the next stage of the disease during the study period.


Ooh more good statistics. The details there is a little out of place but I think it works well enough by reinforcing the stats after it so its not a huge problem to be having in there.

However, adverse reactions in the clinical trial results sparked controversy. 7.3% of patients treated with the drug experienced brain hemorrhage (compared to 9% in the placebo control group), and 12.6% experienced brain swelling (compared to 1.7% in the placebo control group).

Alzheimer's disease experts remain divided on the impact of these changes in the drug on patients and families. Dr. Ron Petersen, a specialist at Mayo Medical Center, believes that the drug's effect is modest but clinically meaningful. Even if it only delays disease progression for a few months, it could provide Alzheimer's patients with more time to live and work independently.


Well that seems like some pretty bad side effects. That's a good point to bring that up there. Showcasing of course this isn't perfect and what might be the more negative points of this being approved.

Maria Carrillo, chief scientist at the Alzheimer's Association, stated that this clinical trial is important because it demonstrates that targeting amyloid with drugs can slow the progression of Alzheimer's disease. Delaying cognitive decline in the early stages of Alzheimer's disease has significant implications, allowing patients to spend more time with loved ones, enjoy family life, travel, take vacations, and fulfill their bucket lists.

Eisai stated that drugs targeting Aβ can cause side effects, including brain swelling and brain bleeding, and lecanemab is no exception. However, most patients experience mild or no symptoms.


Well it seems like the effects are quite good and also quite helpful even if it isn't a complete cure and while those numbers aren't perfect with regards to side effects it does seem the risk is fairly low. Quite nicely argued there.

According to published reports, three Alzheimer's disease patients died during clinical studies of the drug, two of them from strokes caused by brain hemorrhages. Eisai mentioned that the two deaths were due to other health problems while the patients were taking blood-thinning drugs, so these deaths cannot be attributed to the Alzheimer's disease drug.

Professor Robert Alexander from the University of Arizona, chairman of the FDA Peripheral and Central Nervous System Drugs Advisory Committee, commented that based on the results of clinical trials, lecanemab has side effects, but the monitorable nature of these side effects and the benefits to patients are evident.


Well it seems like a good conclusion. I love that you're conclusion is based on some facts that someone else came to as well, giving it much more of an informational feel and making it all feel more valid. Quite nicely done overall.

Aaand that's it for this oneee!!!

Overall

Overall I would say quite nicely done here. It brings up some good facts which I did not have time to verify but if they are all true, this is quite well structured and brings across a compelling and hopeful case for this new drug.

As always remember to: Take what you think was helpful and forget the rest!

Stay Safe and Have a Nice Day!
Kate





Love is friendship that has caught fire. It is quiet understanding, mutual confidence, sharing and forgiving. It is loyalty through good and bad times. It settles for less than perfection and makes allowances for human weaknesses.
— Ann Landers