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re: FDA approves first new Alzheimers drug in 20 years
Posted on 6/7/21 at 7:13 pm to Jim Rockford
Posted on 6/7/21 at 7:13 pm to Jim Rockford
Considering how debilitating, progressive and ultimately lethal Alzheimer’s is, I wonder How bad the side effects have to be for people to say this isn’t worth it.
Also a great article to see a little bit about how the FDA works.
Often FDA approval happens after a lot of tweaking of data and approaches to doses and the trials themselves.
Also a great article to see a little bit about how the FDA works.
quote:
Aduhelm's pathway to regulatory approval has not been without challenges. As part of the phase III process to obtain FDA approval, a medication must be proven effective in two similar clinical trials. Aduhelm was tested in two such trials -- ENGAGE and EMERGE -- but these were discontinued in March 2019 after an independent data monitoring committee found that the medication didn't seem to be making enough of an impact.
quote:
However, a later analysis was performed by Biogen in consultation with the FDA and included additional data that wasn't available earlier when the trials were discontinued. This subsequent analysis showed more promising results and included greater numbers of patients taking higher doses of the drug over longer periods of treatment. It found that Aduhelm was effective in reducing beta-amyloid in the brain and slowing clinical decline in dementia.
Often FDA approval happens after a lot of tweaking of data and approaches to doses and the trials themselves.
This post was edited on 6/7/21 at 7:17 pm
Posted on 6/7/21 at 7:14 pm to SammyTiger
quote:
Considering how debilitating, progressive and ultimately lethal Alzheimer’s is, I wonder How bad the side effects have to be for people to say this isn’t worth it.
Death is better than progressive Alzheimers
Posted on 6/7/21 at 7:14 pm to SammyTiger
It’s a truly terrible disease
Posted on 6/7/21 at 7:28 pm to SammyTiger
quote:
Considering how debilitating, progressive and ultimately lethal Alzheimer’s is, I wonder How bad the side effects have to be for people to say this isn’t worth it.
I think my dad was in this study. I remember him getting infusions in his trial and I also remember him having one issue with brain swelling. I am not sure how they dealt with that but my dad passed away at 95 last year and had the disease for probably 15-20 when it was first noticed. He was in a drug study in his mid 80's and I dont remember how long he was in the study. He continued to decline mentally but at a much slower rate at least that is what I believe. He went into steep decline his last 1-2 yrs.
This post was edited on 6/7/21 at 7:29 pm
Posted on 6/8/21 at 5:59 am to SammyTiger
How long was this in trials and the FDA approval process? Now do the current Covid vaccines.
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