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Today the FDA approved Biogen/Eisai’s powdered protein antibody Aduhelm (generic name aducanumab) for AD treatment through the accelerated approval channel
.
This approval is based on the biomarker that Aduhelm reduces the concentration of central powdery protein.
According to regulations, the drug needs to show efficacy in a controlled trial after it is marketed
Drug source analysis
The application discussed by the expert group last year was mainly based on the results of three trials, including Phase III clinical Emerge as the main data, Phase I clinical 103 trial, and another failed Phase III Engage as an auxiliary
.
Adu is one of many powdery protein pathway inhibitors.
Emerge and Engage, two phase III clinical trials with almost identical designs, were terminated because of ineffective interim analysis
The FDA does not necessarily follow the expert group’s opinions, but the expert group has almost 0 votes in favor of still listing this is the beginning of the article
.
Even Exondys51, which has caused huge repercussions, has 3 votes in support.
How can you embarrass the expert group
Adu is not much different from other similar drugs.
The only difference is Biogen's squeeze on its own data and approval policies
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Phase III clinical trials were terminated due to invalidity and retrospective analysis of successful listings.
Of course, you can also say that this approval was not based on these two phase III clinical trials (at least not based on the primary endpoint results)
Of course, the most serious injury is the FDA itself
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After decades of hard work, FDA, especially the discipline in landmark events such as thalidomide, has become the world's gold standard for new drug approval
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The original article of the United States Chinese Medicine Source, please indicate the source and add a hyperlink or QR code (below) for reprinting.
U.
