Anyone else prevented from receiving Biogen’s Aducanumab?
Posted: Sun Oct 27, 2019 6:17 pm
Hi There,
My mom was diagnosed with the early stages of AD a little over a year ago. She enrolled in Biogen’s aducanumab trial, but before she could take the last medical test to qualify, in March of this year literally days before she was to begin the trial, Biogen canceled the trial due to a statistical futility analysis. Upon learning that Biogen took another look at the data and now has decided to seek approval of the drug from the FDA, we contacted my mom’s trial coordinator to try to begin taking the drug, but were told that only those who actually began receiving the drug already would be permitted to have access to it while Biogen applies for and awaits FDA approval. We are heartbroken, as we understand this process could take years, and my mom can’t afford to wait years.
I was wondering if there are others out there who might be in this situation. It doesn’t seem fair that my mom went through the process of signing the consent forms and going through the lengthly medical tests to get qualified, and on the eve of that qualification, Biogen pulled the plug on her, and now won’t give her the drug.
There can be power in numbers, so perhaps if enough people are in this situation a case could be made to either Biogen or the FDA to open up access to this potentially powerful drug for those whose lives are crumbling and cannot afford to wait. Any thoughts or insights would be much appreciated.
Warmly,
DP
My mom was diagnosed with the early stages of AD a little over a year ago. She enrolled in Biogen’s aducanumab trial, but before she could take the last medical test to qualify, in March of this year literally days before she was to begin the trial, Biogen canceled the trial due to a statistical futility analysis. Upon learning that Biogen took another look at the data and now has decided to seek approval of the drug from the FDA, we contacted my mom’s trial coordinator to try to begin taking the drug, but were told that only those who actually began receiving the drug already would be permitted to have access to it while Biogen applies for and awaits FDA approval. We are heartbroken, as we understand this process could take years, and my mom can’t afford to wait years.
I was wondering if there are others out there who might be in this situation. It doesn’t seem fair that my mom went through the process of signing the consent forms and going through the lengthly medical tests to get qualified, and on the eve of that qualification, Biogen pulled the plug on her, and now won’t give her the drug.
There can be power in numbers, so perhaps if enough people are in this situation a case could be made to either Biogen or the FDA to open up access to this potentially powerful drug for those whose lives are crumbling and cannot afford to wait. Any thoughts or insights would be much appreciated.
Warmly,
DP