2 ms·
> ADUHELM is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease. - https://www.biogencdn.com/us/aduhelm-pi.pdf https://www.bi
by burkaman 5y ago
> ADUHELM is an amyloid beta-directed antibody indicated for the treatment of Alzheimer’s disease.
- https://www.biogencdn.com/us/aduhelm-pi.pdf https://www.biogencdn.com/us/aduhelm-pi.pdf
I believe the advisory panel's position is that it is not indicated for the treatment of Alzheimer's and that Biogen should not be allowed to say this.
In their press release (https://investors.biogen.com/news-releases/news-release-details/fda-grants-accelerated-approval-aduhelmtm-first-and-only https://investors.biogen.com/news-releases/news-release-deta...), they explicitly describe it as an "Alzheimer's disease treatment". Again, I think the advisory panel considers this untrue, and certainly unproven.
The FDA could have said "this drug is safe and may be sold, but you may not describe it as an Alzheimer's treatment, and you must explicitly state that it has been found to be ineffective as an Alzheimer's treatment in clinical trials".