Celebration Thread! Biogen is going to the FDA with Aducan.

Alzheimer's, cardiovascular, and other chronic diseases; biomarkers, lifestyle, supplements, drugs, and health care.
NF52
Support Team
Support Team
Posts: 1846
Joined: Tue Oct 25, 2016 9:41 am
Location: Eastern U.S.

Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby NF52 » Mon Oct 28, 2019 2:25 pm

JohnP wrote:Is this a good choice for a person with one copy of APOE4? Versus Cortexyme (gingivitis antibiotic?)
Trying to decide between 2 clinical trials?
Thanks
John P

Way beyond my pay grade (which is zero!) to answer, JohnP. It's possible that taking Cortexyme would not preclude your participation in the trial. If you find a location that works for you, and they are "actively recruiting", you should be able to click on that and see a name and contact number. I found the people at my Study Site incredibly helpful even in the first phone call. There were times, like when I had to take prednisone for poison ivy, that they had to check with the Medical Directors at the national level to find out whether I stop the study drug/placebo during those 2 weeks. (I did, then started right back on it.) So you may want to start with gaining some information from a study site and go from there.
4/4 and still an optimist!

JohnP
Contributor
Contributor
Posts: 7
Joined: Wed May 30, 2018 7:44 am

Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby JohnP » Mon Oct 28, 2019 2:27 pm

Thank you!

J11
Contributor
Contributor
Posts: 2097
Joined: Sat May 17, 2014 4:04 pm

Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Mon Oct 28, 2019 6:01 pm

JohnP, this is such a wonderful and unexpected early Christmas present!
If everything had stayed on script we might not have had this celebration for years.
It takes so many years for anything to happen that you start losing track of time.
But here we are and this might be before the FDA in a few months, it is startling.

And the benefits that we can see here are large.
The figures (admittedly this is for the early stage trial with smallish numbers) that I posted show about at least a 2 1/2 years stasis for decline in the high dose group. I cannot think of any other drug in the last 20 years that has had such a large population scale impact on quality of life. Breakthrough cancer drugs sometimes have survival benefits measured in weeks often with side effects. This is not weeks, this is years and for patients who are otherwise healthy that means 2 1/2 years of more healthy living.
This is a substantial boost.

This is consistent with the impression that I have been forming over the last few years with taurx, Grifols, etc.. that there would be large benefits on the way for AD treatment. This is only the first wave which is focused on amyloid/tau. I wonder what happens when they stop the neurodegeneration and then add in a brain nutrient such Souvenaid, etc. To date I am not sure whether I can remember any strong clinical support for actually increasing cognitive functioning in those with clinical dementia, though I will be very excited when this is published. Combination treatment for Alzheimer's! It is hard to imagine that we have suddenly reached such a place.

The suggestion that the FDA is leaning towards more clinical evidence is a disappointment. I simply do not understand why they have talked about this for 7 months and then want more study. As soon as questions about the futility analysis were raised, trials should have immediately resumed. They couldn't have sorted out the answer without the trials; that is what they are for. If you don't know you need more empirical evidence not more rhetoric. Basically they debated it for all these months and then decided they needed more evidence. I do not understand why the FDA doesn't simply allow immediate marketing authorization as an amyloid lowering agent without efficacy claims which could be added later. Go back to the standard where safety has been demonstrated
and let people make up their own minds from there. The phase 3 Emerge result is very solid and it is consistent with a large body of research into amyloid; it can hardly be called a fluke. When you move beyond the topline results there will be undoubtedly be
highly dramatic results such as conditioning cognitive results on amyloid reduction that will amp up patient demand for quick approval.

Hopefully the word can get out there and people will realize that aducan is for everyone at a certain age, not just other people.
When we can clearly say that amyloid is a neurotoxin of the brain and that it is universally present in humans over 90, then the yardsticks of life can start to shift around.

NF52 is right that the big question of how to make the choice is beyond our knowledge base. However, one observation to keep in mind is that no Alzheimer drug has ever demonstrated efficacy until aducan; we have been waiting for millennia. Thus, the prior probability that any treatment will actually be effective is almost zero. If it were me, I would go amyloid lowering as this has shown effectiveness ( though it is a tough call that you will need to make yourself).

And with the gum issues, I am not clear why one could not receive the same benefits through diligent oral health. I have been using my waterflosser lately and my mouth feels much cleaner; possibly with less bacteria causing AD. You might want to read up on this further to check if this is consistent with the evidence gathered to date. For example, do they exclude patients from the trial if the y have excellent oral hygiene?

taurx is obviously another one to keep in mind. They have already posted very strong phase 3 results which they are now confirming. Would be highly worthwhile to look into methylene blue/LTMX.
viewtopic.php?f=4&t=3890&p=45941&hilit=celebration#p45941
Last edited by J11 on Wed Oct 30, 2019 7:25 pm, edited 1 time in total.

J11
Contributor
Contributor
Posts: 2097
Joined: Sat May 17, 2014 4:04 pm

Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Mon Oct 28, 2019 10:35 pm

hmm, that's funny, I wonder whether they have thought of doing a GWAS on response or even ARIA in the aducan trials.

J11
Contributor
Contributor
Posts: 2097
Joined: Sat May 17, 2014 4:04 pm

Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Fri Nov 01, 2019 8:27 pm

The obvious question that many of those on forum must be asking themselves is: Should I begin dosing with aducan as soon as it is approved?

The figure below shows that amyloid is present even at ages from mid 40s on. {I am not totally sure how the units included on these figures relate to the units of the phase 3 trials; it would be helpful to know this information.} There might be a mass rush by possibly tens of millions of people in these earlier years to remove this amyloid from their brains once aducan becomes available. Hopefully with all the big money that will be in the system once this is approved that solid science can be done to answer the big outstanding unknown related to the efficacy of such treatment. It is going to be scary for these people because it simply might not be possible to determine the effect of anti-amyloid treatment on patients who might not be expected to develop cognitive symptoms possibly for decades.


https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4570860/


Early Amyloid.PNG




An important aspect of the news that does not seem to have been emphasized enough is that we should have definitive evidence on the effectiveness of aducan with only a few more months of additional dosing. With all 3200+ patients receiving active treatment (possibly on high dose) a rapid convergence to statistical significance would be expected.

The low dosing arm at last readout had reached -0.16 amyloid change and would be within about half a year of reaching the same level of amyloid clearance as had occurred with those who had been treated with high dose during the first 18 months. See my new extrapolation below for the low dose arm using the new high dose trajectory starting at 18 months, see the added green line to the blue line at 18 months. Perhaps the real celebration will need to wait for ICAD 2020; it will be very comforting to have this overwhelming patient data to support or refute claims of efficacy and this should be knowable soon. We will all have to wish that the interlude since the futility analysis hasn't in some way scuttled the entire effort.


Aducan Update.png



From my reading online, it appears that under Plan B of Medicare only those on label would be eligible for compensated
treatment. Yet, I am still not entirely clear about what happens when they dose the placebo arms from the phase 3s. My hunch as of now is that even moderate AD patient should receive benefit, though this does run counter to many years of clinical trial results. The primary reason why they have moved to dosing amyloid drugs in mild AD is because it had not been successful in the later stages.
You do not have the required permissions to view the files attached to this post.

J11
Contributor
Contributor
Posts: 2097
Joined: Sat May 17, 2014 4:04 pm

Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Sun Nov 03, 2019 11:28 am

I am continuing to process this latest development with aducan.

The Political implications have as of yet not been mentioned (here at least). Those with epsilon 44, deterministic
dementia variants or even those with high polygenic scores would reasonably be expected to be drawn towards a communitarian ethos. As dementia progresses an overwhelming amount of resources are necessary which would financially strain those of almost any social background. If we are now approaching a world in which the ~7 million Americans with epsilon 44, ~60 million epsilon 43s, ~~50 million non-epsilon 4s at high risk (high polygenic risk), ~? million with deterministic genotype will be able to plan and effectively manage their cognitive health, then it is reasonable to expect that the political spectrum will shift considerably to the right. Cognitive impairment during aging is now probably the main driver for the need of government; without such a need the government's role becomes less obvious.

In my own family, the difference between the demented and non-demented branches has been dramatic. In the non-demented branch, there were family who lived a century without ever needing any particular medical intervention, while in the other branch intense medical interventions spanning decades were needed. If all of those in my family could age through without dementing illness emerging, then what good or service could government offer me that I could not simply buy for myself?

Dementia caused us to demand a range of services that placed tremendous financial stress on us and on our community. Without dementing illness, it becomes entirely plausible for us to live without economic, social and/or medical dependency on others. Life could be based more upon a rational appraisal of what is in our best self-interests, then the servitude that results when one needs to ask others for assistance. Such a future suggests free over command-style markets. We might now be approaching an age of libertarianism, in a manner that it has never been truly possible before, given the enormous amount of dementing illness that has been manifest and latent in the community.

Interestingly, while this might turn out to be the long-term direction, actually arriving in such a future might require a detour or two. For as an effective treatment now appears to be on the horizon, the question of financing this breakthrough must also be considered. As I noted in an earlier post, tens of millions of Americans who are decades away from frank cognitive impairment might want to proactively manage their dementia risk and start treatment on approval of aducan. Personally, I will put 10 grams of aducan
on my Christmas list for Santa. Tens of millions of people wanting a treatment that might be well beyond their financial resources would seem to speak more to an egalitarian than libertarian perspective. Given the nature of the global economy, one would not find it overly surprising if an override of patent as occurred with HIV treatment might occur. However, there are a range of other amyloid and other treatments working through clinical trials and of course with lifestyle treatments that involve preventing illnesses possibly decades away, one could surely speculate that revenue maximization would occur at very reasonable price point. As seen with cholesterol drugs, widespread financial success occurred when price was set within the budget of typical Americans.

J11
Contributor
Contributor
Posts: 2097
Joined: Sat May 17, 2014 4:04 pm

Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Wed Dec 04, 2019 3:02 pm

Very exciting everyone!

CTAD 2019 is underway!

Back in October when the aducan news broke, December seemed like forever away.
But, now it's here!

https://www.ctad-alzheimer.com/files/fi ... r%2019.pdf

We have just missed the Keynote 1 that started at 4:30 and was going to discuss Results.
What could that possibly mean other than aducan?

The big results for aducan though are for tomorrow.

Are they kidding?
8:00 AM tomorrow?
At least it's California time! Maybe they'll be relaxed about the time thing.

https://www.ctad-alzheimer.com/files/fi ... r%2019.pdf

J11
Contributor
Contributor
Posts: 2097
Joined: Sat May 17, 2014 4:04 pm

Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Wed Dec 04, 2019 3:23 pm

I hope that they release a pdf soon after or during(?) the presentation. There is obviously an enormous interest in these results and it would be helpful if they could let us sift through everything instead of being given media headlines. The dataset might be somewhat difficult to understand with the usual hurrays or boos, so letting the data speak for itself would seem preferable.

Does anyone have any idea about the data release intentions for the aducan presentation scheduled for tomorrow?
Last edited by J11 on Thu Dec 05, 2019 6:07 pm, edited 1 time in total.

J11
Contributor
Contributor
Posts: 2097
Joined: Sat May 17, 2014 4:04 pm

Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Thu Dec 05, 2019 9:50 am

Has the price of Biogen really increased by $20 in the last 10 minutes?

Letting the people with money (and one hopes intelligence) sort everything out for us makes deciphering the aducan results much easier.

Hurray!?

J11
Contributor
Contributor
Posts: 2097
Joined: Sat May 17, 2014 4:04 pm

Re: Celebration Thread! Biogen is going to the FDA with Aducan.

Postby J11 » Thu Dec 05, 2019 11:05 am

An investor Q&A with Biogen scheduled for 5 PM today.
http://investors.biogen.com/events-and- ... ing-events

Anyone know where we can access the pdf from today's CTAD presentation?


Return to “Prevention and Treatment”

Who is online

Users browsing this forum: No registered users and 19 guests