2y ago

The first drug that slows Alzheimer's has finally received FDA approval

www.engadget.com The first drug that slows Alzheimer's has finally received FDA approval | Engadget

Japanese drugmaker Eisai and US-based Biogen have received FDA approval for Leqembi, making it the first approved treatment available that can slow the progression of Alzheimer’s in patients..

Japanese drugmaker Eisai and US-based Biogen have been working together on advancing research in the space of Alzheimer’s for nearly a decade. Finally, the FDA, granted the fruits of that labor, Leqembi, its blessing for intravenous use. This marks the first approved treatment that can slow the progression of Alzheimer’s.

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For those interested. This is similar to Aduhelm in that it is an amyloid binding drug. Amyloids proteins have long been thought to be central to Alzheimer's disease since it was first described by Dr. Alois Alzheimer in 1906, where during his autopsy of a 50-year who died while suffering memory loss, disorientation, and other classical symptoms of the disease noticed "senile plaque" had accumulated on the brain which is usually found in much older patients. In the 1980s chemical analysis of the plaque indicated that it was made of beta-amyloids and from there we've been attempting to target that in order to prevent Alzheimer's disease.
The statement that the drug "will" slow Alzheimer's is editorial so to say. After their third phase trail, the results were sobering.
27% decrease in the rate of progression for patients treated with Leqembi, compared to those receiving a placebo.
Which 27% is still 27%. But this drug is looking to go for a price of $23,000 to $27,000 per year (drug cost alone, infusion and doctor's office visits may shoot this price upward towards $90,000/year). Strangely the article says:
Current rules mean that it’s unlikely to be covered by Medicare.
Which there was Senate hearing where the exact opposite was indicated. Medicaid will likely have the 20% co-pay for patients. That said, for the United States, this drug will be outside of the reach of many not 65 or older.
Additionally, we're still at the nexus of this topic and not knowing full well where to go for the treatment in Alzheimer's. Many competing ideas of the full scope of Alzheimer's disease still exist from tau tangles to neuron degeneration. It's indisputable that beta-amyloids do have a part in Alzheimer's the question remains as to how large a role it plays in mental decline and the low positive outcomes of beta-amyloids has served as fuel for discussion of other ideas. That said, penicillin failed twice in clinical trials, but today nobody would question antibiotic theory, so take the failures with a grain of salt perhaps? But this all does indeed go to show, this area of research is dizzily complex and fluid to say the least.
As for the "first" distinction and that Aduhelm has been FDA approved since 2021. Leqembi is the FIRST to receive the full FDA approval. Aduhelm still operates under the accelerated approval and is still pending a full review. Much like how we had COVID vaccines approved under the accelerated program first and then in 2022 the FDA gave many of them full approval.
It's good this drug has received the first full approval for the treatment of beta-amyloids. But suffice to say, based on the approval material, we still have yet a LONG way to go in Alzheimer's research.
- This is the first time I’ve opened a post on Lemmy and seen such a valuable response. Thanks for being here and taking the time to post this. Super interesting and informative stuff.
  My ex wife’s dad is in the middle stages of early onset dementia (he’s in his mid-60’s) and I’m thinking it’s a bit too late for this to be helpful. But seeing this progress gives me hope for my ex-wife and her brother who both have very high risk of dementia (grandma, their dad, and their uncle all suffer(ed) from it, dad and uncle are both in similar stages with dad a couple years behind uncle… really sad shit).
  I really hope we get this figured out in the next 20 years.
- We are starting to see the first drugs on the market that utilize the amyloid beta pathway in some fashion because research in the 90's and 2000's were absolutely convinced that this pathway was the lynchpin to the disease. My understanding of the disease (I studied biotech but not Alzheimer's specifically) is that amyloid beta plaques are more of a side effect of whatever is really going on than the main show. And unfortunately the mechanism of dementia in general is not really well understood, Alzheimer's included.
  These sobering results are not really that surprising because treating the amyloid beta plaques after they have formed is sort of like trying to prevent spoiled meat by removing the maggots that have accumulated on it.

So good to see some advancement with this! I’ve watched two family members wither away because of it.
- Currently doing that. It’s fucking brutal.
  
  I’m so sorry to hear that, it fucking sucks. Cherish the moments that you have left.

I wonder how this works in comparison to the RTMS therapy being used to slow/halt progression out of Canada?
Either way, it's great to see advancements on this front. The fake data debacle the other yeas was pretty disheartening.
- Yeah, any news like this is heartening but I always take it with a large grain of salt. I’ve got family member affected by Alzheimer’s so it really hits home.

Unfortunately this drug and others like it are not a revolution in Alzheimer's treatment. It is VERY questionable if the modest positive impact is worth the known adverse effects, and many in the healthcare industry (myself included) are concerned that these approvals prey on desperate families willing to pay exorbitant prices for any shred of hope.
"Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events. Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease."
https://www.nejm.org/doi/full/10.1056/NEJMoa2212948

FWIW, I found this an interesting related article
https://www.science.org/content/blog-post/lilly-s-new-donanemab-data-alzheimer-s

Whenever I hear this kind of news, I always think of the people who just barely missed this. Or will miss this as it takes time to roll it out (I assume).
- For sure. Dark thought, but I wonder if gen xers and millennials on their death beds will experience a novel form of grief when effective therapies for terminal illnesses are cheap and available, but need to be administered before onset to be effective. Maybe there's a word for it in German.

Hooray science and progress!

This is really good! I really hope it is affordable as well.
- Unfortunately the article states a yearly treatment cost would be about $90K with all expenses factored in. Patients with Medicare will likely not be able to get coverage for this, and Medicaid will still require a copay of 20%.
  Like every other industry, pharmaceutical companies are profit driven and will maximize their revenue whenever possible, especially when they know the patient population is desperate.
  A big example of this was when Pfizer discontinued their research program to cure heart disease, since it is more profitable to charge patients for statins for the rest of their life than it is to cure them.

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