Celebration Thread: Donanemab

Alzheimer's, cardiovascular, and other chronic diseases; biomarkers, lifestyle, supplements, drugs, and health care.
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J11
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Celebration Thread: Donanemab

Post by J11 »

So much celebrating!
It is actually hard to keep up with it all.

I am not sure when the pdufa is for Donanemab.
I am going to go with the generic Valentine's countdown this time.

https://www.timeanddate.com/countdown/v ... nt=cursive


Donanemab has some interesting features that we can explore on this thread.
J11
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Re: Celebration Thread: Donanemab

Post by J11 »

I was already for yet more celebrating and then the FDA rejects Donanemab for accelerated. No, Romeo. The basis of this decision was that Donanemab did not have the required 100 patients on treatment for 12 months in the phase 2. Remember that with Donanemab they stop treatment once amyloid is cleared; about now they are probably wishing they had continued with the dosing for a full 100 patients so they would be in compliance with the technical regulations.
Conspicuously, there was no longer any mention of a deficiency in regard to the amyloid clearance as biomarker for cognitive benefit question.

There is a fair amount of interesting science with Donanemab so when we get closer to full approval this can be discussed here.
J11
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Re: Celebration Thread: Donanemab

Post by J11 »

There was not much posting to this thread and then they post the phase 3 results and they are great!
Not easy to keep up with all the great news anymore.

There are interesting features that were added into Trailblazer, so I will be very interested to see a more complete dataset. I would really like to see where the result landed in the CDR-sb vs. SUVR amyloid space. Topline 36% slowing on CDR-sb with dual amyloid and tau selection. The numbers are moving upwards; it is not easy to say that is not clinically meaningful anymore. One also wonders how the subgroups might start to crystallize.


https://investor.lilly.com/news-release ... functional
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