Experts again expressed their opposition to the approval of the Alzheimer’s treatment’Adukanumab’, which is expected to be approved in June.
According to Biopamadaev, a medical journal in the United States, on the 1st (local time), three doctors who participated in the US Food and Drug Administration (FDA) Drug Advisory Committee (PCNS) in November of last year are Again, the FDA’s approach to it was questioned.
The FDA will decide whether to finalize adukanumab by June 7th. The previous day, a foreign press reported that the FDA is under pressure over the need to approve Alzheimer’s treatments, and certain senior members of the FDA have a favorable view of adukanumab, so the drug may be approved.
Accordingly, the three professors who are advisory members of the FDA have expressed their opposition to adukanumab in an editorial in the JAMA International Journal.
Biogen conducted phase 3 clinical trials of adukanumab with the same structure into’EMERGE’ and’ENGAGE’ at the same time. However, the results of each test were contradictory. EMERGE met the evaluation index, but ENGAGE failed to prove its effectiveness.
Professors Caleb Alexander, Scott Emerson and Aaron Kesselheim mentioned this in editorials. The advisory committee held in November of last year also pointed out that it is unreasonable to make a decision with only successful phase 3 clinical trials, omitting the failed phase 3 results. These are among the 10 members who recommended opposition to Adukanumab at the time.
They said, “It is difficult to approve adukanumab only with the results of EMERGE, which has proven its effectiveness,” and said, “A substantial evidence of efficacy is needed.”
It also claimed that the FDA worked closely with Biogen to analyze the data from the experiment. There is an unusual cooperation between the FDA and Biogen.
“Ultimately, there is currently no convincing evidence to support Adukanumab’s approval,” the professors stressed.
Reporter Kim Ye-na [email protected]
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